Oxygenator, Cardiopulmonary Bypass
FDA product code DTZ · 241 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.4350
- Review panel
- CV
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-11-12 – 2026-09-14
DTZ
2026-09-14
DTZ
2026-03-16
Lifemotion Disposable Membrane Oxygenator
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DTZ
2026-03-12
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);
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DTZ
2025-12-12
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
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DTZ
2025-11-24
Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
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DTZ
2024-09-12
Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
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DTZ
2024-07-10
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
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DTZ
2024-06-12
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
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DTZ
2023-11-16
D100 KIDS; D101 KIDS
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DTZ
2023-11-08
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U
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DTZ
2023-11-01
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
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DTZ
2023-04-06
Affinity Fusion™ Oxygenator System
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DTZ
2023-02-23
OXY-1 System
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DTZ
2022-12-01
CentriMag Pre-connected Pack
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DTZ
2022-01-28
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
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DTZ
2021-12-17
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2
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DTZ
2021-12-10
AMG PMP Infant
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DTZ
2021-09-16
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
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DTZ
2021-07-12
EOS PMP
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DTZ
2021-04-01
AMG PMP Pediatric
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DTZ
2020-10-23
OXY-1 System
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DTZ
2020-09-18
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
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DTZ
2020-08-13
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
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DTZ
2020-06-12
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
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DTZ
2020-02-28
Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
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DTZ
2019-09-27
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
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DTZ
2019-05-17
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
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DTZ
2019-04-13
INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
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DTZ
2019-04-12
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
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DTZ
2019-03-18
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)
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DTZ
2018-06-22
Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
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DTZ
2018-03-29
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
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DTZ
2018-03-15
INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
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DTZ
2017-11-20
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
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DTZ
2017-10-25
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
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DTZ
2016-12-06
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
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DTZ
2016-09-21
Affinity NT Oxygenator with Cortiva BioActive Surface
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DTZ
2016-02-26
TandemLung Oxygenator
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DTZ
2013-10-08
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
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DTZ
2013-03-20
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
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DTZ
2013-03-13
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
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DTZ
2013-03-13
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
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DTZ
2013-03-13
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
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DTZ
2013-03-13
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
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DTZ
2013-03-13
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
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DTZ
2013-02-12
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
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DTZ
2013-01-22
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
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DTZ
2012-12-14
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
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DTZ
2012-10-17
INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
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DTZ
2012-09-14
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
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DTZ
2012-08-24
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
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DTZ
2012-08-22
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
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DTZ
2012-07-26
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
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DTZ
2012-07-23
INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
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DTZ
2012-05-11
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
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DTZ
2012-04-05
INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
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DTZ
2011-09-15
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
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DTZ
2011-03-08
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
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DTZ
2011-03-04
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
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DTZ
2011-02-15
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
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DTZ
2010-12-08
QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
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DTZ
2010-04-30
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
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DTZ
2009-12-07
QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
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DTZ
2009-10-29
QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
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DTZ
2009-10-19
APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2009-09-18
MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT
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DTZ
2009-09-18
MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
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DTZ
2009-06-12
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
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DTZ
2009-05-15
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
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DTZ
2009-02-18
QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
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DTZ
2009-02-02
VISION HOLLOW FIBER OXYGENATOR WITH HA COATING
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DTZ
2008-10-29
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2008-02-29
SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
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DTZ
2008-01-23
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
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DTZ
2007-10-29
D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
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DTZ
2007-10-23
NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
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DTZ
2007-07-23
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
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DTZ
2007-07-16
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
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DTZ
2006-08-24
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR
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DTZ
2006-08-22
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
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DTZ
2006-06-02
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
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DTZ
2005-09-15
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
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DTZ
2005-03-08
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2005-02-01
D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
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DTZ
2004-03-03
CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR
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DTZ
2004-03-03
RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
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DTZ
2004-01-13
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
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DTZ
2003-05-02
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
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DTZ
2003-03-31
VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
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DTZ
2003-02-26
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
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DTZ
2002-10-22
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
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DTZ
2002-09-27
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
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DTZ
2002-08-14
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
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DTZ
2002-04-04
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2002-02-26
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
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DTZ
2002-01-08
APEX ADULT HOLLOWE FIBER OXYGENATOR
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DTZ
2001-12-27
D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
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DTZ
2001-12-11
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
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DTZ
2001-11-16
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
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DTZ
2001-10-04
MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
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