Ventilator, Emergency, Manual (Resuscitator)
FDA product code BTM · 208 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5915
- Review panel
- AN
- Implant
- No
- Life sustaining
- Yes
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-24 – 2025-11-24
BTM
2025-11-24
BTM
2025-04-25
butterflyBVM
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BTM
2023-03-18
EOlife®
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BTM
2022-08-18
Sotair Device
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BTM
2021-08-26
Disposable Manual Resuscitator
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BTM
2018-12-07
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
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BTM
2018-05-11
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
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BTM
2016-08-29
Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator
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BTM
2012-01-13
BABI PLUS NEONATAL RESUSCITATION BAG
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BTM
2011-01-28
AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
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BTM
2011-01-06
NEOPOP INFANT RESUSCITATOR WITH FLOW METER
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BTM
2010-09-17
REVIVATOR
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BTM
2010-02-05
POCKET BVM
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BTM
2008-10-15
DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE
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BTM
2008-09-12
SAVE RESUSCITATOR
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BTM
2008-01-31
RESUSCITATION TIMER, MODEL L770-CPR
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BTM
2007-09-12
NEOPIP INFANT RESUSCITATOR
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BTM
2007-04-20
GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
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BTM
2006-10-18
RESUSCITATION TIMER, MODEL L770-CPR
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BTM
2006-03-22
HSINER RESUSCITATOR
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BTM
2005-12-23
AMBU MARK IV RESUSCITATOR
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BTM
2005-12-20
AMBU MARK IV BABY RESUSCITATOR
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BTM
2005-08-29
PVC AND SILICONE MANUAL RESUSCITATORS
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BTM
2005-03-11
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
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BTM
2004-11-15
AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR
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BTM
2004-11-12
AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS
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BTM
2004-08-05
STURDY MANUAL RESUSCITATOR
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BTM
2004-07-16
MERLIN RESUSCITATOR
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BTM
2004-02-06
BAWMED E-Z BAG RESUSCITATOR
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BTM
2004-01-30
VADI MANUAL RESUSCITATOR
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BTM
2003-06-26
SMART BAG MO
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BTM
2003-02-11
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
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BTM
2003-02-07
NELLCOR INDGO MANUAL RESUSCITATOR
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BTM
2002-10-11
OEMEDIC INTERNATIONAL INC. BESMED SILICONE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK AND RESERVOIR
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BTM
2002-10-08
SIMPLIFY COMPACT RESUSCITATOR
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BTM
2002-10-04
PMX COMPACT RESUCITATOR
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BTM
2002-10-04
ACUTEVENTILATOR
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BTM
2002-10-01
PMX DISPOSABLE BAG MASK RESUSCITATOR
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BTM
2002-07-30
OEMEDIC INTERNATIONAL INC. BESMED SINGLE USE ADULT, CHILD, INFANT MANUAL RESUSCITATOR WITH MASK & RESERVOIR
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BTM
2002-02-27
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
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BTM
2001-09-18
V*CARE MANUAL RESUSCITATOR
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BTM
2001-06-26
Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
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BTM
2001-06-06
HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
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BTM
2000-05-17
AMBU NEONATE SILICONE RESUSCITATOR
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BTM
2000-03-24
RUSCH MANUAL RESUSCITATOR BAG
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BTM
2000-01-18
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
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BTM
1999-09-13
IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006
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BTM
1999-07-06
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
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BTM
1999-07-01
MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
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BTM
1998-09-18
MANUAL RESUSCITATOR WITH ACE
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BTM
1998-07-16
CPR FILTERSHIELD
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BTM
1998-07-06
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
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BTM
1998-07-06
INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
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BTM
1998-05-21
PLUS REUSABLE RESUSCITATOR
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BTM
1998-03-25
DMR PLUS DISPOSABLE MANUAL RESUSCITATOR
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BTM
1998-01-29
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
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BTM
1997-12-02
OHMEDA INFANT RESUSCITATION SYSTEM
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BTM
1997-10-31
MERCURY MEDICAL REUSABLE CPR BAG
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BTM
1997-09-17
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
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BTM
1997-09-03
ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
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BTM
1997-07-07
MANUAL RESUSCITATOR
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BTM
1997-06-16
DATEX ENGSTOM MANUAL RESUSCITATOR
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BTM
1997-06-13
INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
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BTM
1997-05-15
AMBU SPUR NEONATE
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BTM
1997-02-21
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR
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BTM
1996-08-15
GRAYCO POCKET PUMP
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BTM
1996-07-02
BAGRIGHT INFANT RESUSCITATOR
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BTM
1996-07-02
BAGRIGHT CHILD RESUSCITATOR
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BTM
1996-06-28
RESPOSABLE INFANT RESUSCITATOR
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BTM
1996-06-28
RESPOSABLE CHILD RESUSCITATOR
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BTM
1996-06-28
BAGRIGHT RESPOSABLE RESUSCITATOR
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BTM
1996-06-28
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
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BTM
1996-06-28
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
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BTM
1996-04-26
DMR/CO2 COMBO KTI
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BTM
1996-02-29
MANUAL PULMONARY RESUSICITATOR
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BTM
1996-01-30
MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
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BTM
1995-12-20
BAGRIGHT RESUSCITATOR
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BTM
1995-12-20
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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BTM
1995-11-22
RESPOSABLE RESUSCITATOR
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BTM
1995-09-19
LIFEMASK FACE SHIELD
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BTM
1995-08-28
CAPNO-FLO REGULATOR, CAPNO-FLO
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BTM
1995-06-08
SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC
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BTM
1995-01-05
RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE
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BTM
1994-12-21
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380
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BTM
1994-12-12
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
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BTM
1994-10-28
MATRX HOPE(R) 5 RESUSCITATOR
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BTM
1994-08-18
BNOS MICRO VENT, MODEL AC AND MODEL AO
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BTM
1994-08-11
DISPOSABLE MANUAL RESUSCITATOR
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BTM
1994-05-06
BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS
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BTM
1993-12-14
BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR
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BTM
1993-11-24
INFANT DISPOSABLE BAG MASK RESUSCITATOR
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BTM
1993-11-24
LSP (MODEL 554) BAG MASK RESUSCITATOR
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BTM
1993-10-06
CAPNO-FLO
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BTM
1993-09-03
PRESSURE LIMITING ELBOW
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BTM
1993-04-21
BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT
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BTM
1993-04-06
BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT
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BTM
1993-03-11
AID, CARDIOPULMONARY RESUSCITATION
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BTM
1993-02-05
SPUR INFANT/CHILD W/O PRESSURE-LIMITING VALVE
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BTM
1993-02-03
RESPIRE DISPOSABLE PULMONARY RESUSCITATOR
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BTM
1993-01-22
ODYSSEY
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