Warmer, Infant Radiant
FDA product code FMT · 92 cleared devices
Class 2
General Hospital
- Regulation
- 21 CFR 880.5130
- Review panel
- HO
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1979-03-06 – 2025-01-17
FMT
2025-01-17
FMT
2023-05-30
Babyroo TN300
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FMT
2022-03-02
Giraffe Omnibed Carestation CS1
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FMT
2021-02-12
Panda iRes Warmer, Giraffe Warmer
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FMT
2020-04-02
HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable
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FMT
2020-01-21
Hydro-Temp Neonatal Skin Temperature Probe Cover
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FMT
2018-08-17
NuBorne Infant Warmer
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FMT
2013-02-05
GIRAFFE AND PANDA WARMERS
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FMT
2012-11-02
RESUSCITAIRE WITH AUTOBREATH
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FMT
2012-10-02
GIRAFFE AND PANDA WARMERS
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FMT
2012-09-14
LULLABY TM WARMER
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FMT
2012-07-06
SUNFLOWER WARNER
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FMT
2011-01-21
INFA WARMER I
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FMT
2010-07-21
GIRAFFE AND PANDA WARMERS
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FMT
2009-04-16
MODIFICATION TO: GIRAFFE AND PANDA WARMER
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FMT
2007-08-27
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
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FMT
2007-07-11
GIRAFFE AND PANDA WARMER
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FMT
2006-04-28
V-505 INFA WARMER
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FMT
2003-12-17
PHOENIX INFANT RADIANT WARMER, MODEL 100NWS
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FMT
2002-06-13
RPI REPLACEMENT HEATING ELEMENTS
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FMT
2002-04-12
RPI SKIN OR AIR TEMPERATURE PROBE
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FMT
2001-09-10
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
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FMT
2000-11-17
RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
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FMT
2000-10-10
ATOM INFA WARMER V-505
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FMT
1998-01-05
INCUWARMER
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FMT
1997-10-30
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
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FMT
1997-10-03
BABYTHERM 8004 BABYTHERM 8010
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FMT
1997-08-25
ACCUTEMP-PROBE
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FMT
1997-07-28
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
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FMT
1997-07-16
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
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FMT
1997-05-07
INFANT RADIANT WARMER - MODELS IW910 AND IW920
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FMT
1997-04-03
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
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FMT
1997-02-06
KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)
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FMT
1997-01-23
FIRST TOUCH DISPOSABLES TEMPERATURE PROBES
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FMT
1996-10-01
INFANT WARMER SYSTEM
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FMT
1996-05-01
ACCUTEMP PROBE
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FMT
1996-04-04
TEMPERATURE PROBE-TP650
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FMT
1996-04-04
TEMPERATURE PROBE-TP550
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FMT
1996-04-04
TEMPERATURE PROBE-TP450
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FMT
1996-04-04
TEMPERATURE PROBE-TP350
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FMT
1996-04-04
TEMPERATURE PROBE-TP250
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FMT
1996-04-04
TEMPERATURE PROBE-TP150
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FMT
1996-02-09
DRAGER INFANT RADIANT WARMERN RH600
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FMT
1995-09-25
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
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FMT
1995-09-25
ASTRAL DISPOSABLE SKIN TEMPERATURE PROBE
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FMT
1995-05-03
RW RESUCITAIRE INFANT RADIANT WARMER
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FMT
1995-02-27
DISPOSABLE TEMPERATURE PROBE COVER
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FMT
1994-09-16
STABILET
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FMT
1994-07-05
U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
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FMT
1994-07-01
4002 INFANT SCALE FOR INCUBATORS AND WARMERS
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FMT
1994-03-11
INFANT WARMER
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FMT
1994-02-24
KLEAR-TEMP
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FMT
1994-01-31
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
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FMT
1993-07-23
ADVANTAGE
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FMT
1993-04-23
OHIO INFANT WARMER SYSTEM
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FMT
1992-10-30
VSI 1000
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FMT
1992-06-08
THERMAL PROBE COVER
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FMT
1992-02-12
STABILET INFANT RADIANT WARMER MODEL 2000C
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FMT
1991-07-16
PATIENT WARMER MODEL 100C
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FMT
1989-08-07
PREEMICARE SERIES 2000 INFANT WARMER
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FMT
1988-12-22
MODEL WC-115 MOBILE BASSINET
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FMT
1988-12-22
MODEL WC-107 MOBILE NEWBORN BED
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FMT
1988-12-22
MODEL WC-102 NEWBORN BED & EQUIPMENT CABINET
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FMT
1988-11-22
ACCUTEMP PLUS
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FMT
1988-11-21
OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
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FMT
1988-07-12
SPECIAL PROCEDURES BASE UNIT MODEL 500
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FMT
1988-01-19
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
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FMT
1987-10-20
WARM WEIGH MODELS I-20/W-30 INFANT SCALE
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FMT
1987-10-09
MTC XI UL
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FMT
1987-10-09
NTH 101 UL
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FMT
1987-06-05
BIRTHING ROOM WARMER
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FMT
1987-04-01
MODEL 10200 PREMATURE INFANT INCUBATOR
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FMT
1987-03-04
YSI MODEL 801
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FMT
1986-10-03
OHMEDA AUXILIARY POWER SYSTEM
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FMT
1986-07-15
DELIVERY ROOM WARMER
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FMT
1986-02-26
NEOCARE MODEL 800 INFANT RADIANT WARMER
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FMT
1985-11-08
NEO SHIELD
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FMT
1985-10-17
OHMEDA HEAT REFLECTING PATCH
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FMT
1985-10-16
NEOGUARD REFLECTOR
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FMT
1985-06-07
OHMEDA 5000 INFANT WARMER SYSTEM
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FMT
1985-05-30
BORNING NEONATAL RESUSCITATOIN CENTER
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FMT
1984-05-25
INFANT RADIANT WARMER
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FMT
1984-04-05
INFANT WARMER
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FMT
1984-03-23
OHIO 3300 INFANT WARMER SYSTEM
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FMT
1984-03-23
OHIO 3000 INFANT WARMER SYSTEM
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FMT
1983-12-22
AMEDA NEONATAL RESUSCITATION UNIT-
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FMT
1983-06-22
RESUSCITAIRE
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FMT
1982-01-25
SAGE 2200 STERILE SPECIMEN CONTAINER
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FMT
1981-11-02
WARMING LISTHTS #96H & 96HT
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FMT
1980-10-23
OHIO RADIANT WARMER
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FMT
1979-09-24
TEMP-GUARD TM
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FMT
1979-03-06
INFANT CARE SYSTEM
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