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
1992-12-01
BTM
1992-10-19
LSPI INFANT BAG MASK
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BTM
1992-10-06
RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED
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BTM
1992-09-17
LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
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BTM
1992-09-16
AMBU SILICONE RESUSCITATOR INFAN/CHILD W/OPEN RESO
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BTM
1992-09-16
AMBU SILICONE RESUSCITATOR, ADULT W/OPEN RESERVOIR
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BTM
1992-06-19
SPUR INFANT/CHILD WITH OPEN RESERVOIR SYSTEM
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BTM
1992-06-19
SPUR ADULT WITH OPEN RESERVOIR SYSTEM
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BTM
1992-05-28
MODIFICATION PURITAN-BENNETT INFANT PM2
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BTM
1992-03-09
MER BAG
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BTM
1992-02-27
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
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BTM
1992-01-07
V*CARE MANUAL RESUSCITATOR, CAT#VR-1000
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BTM
1991-12-04
OPOMAT MANUAL RESUSCITATOR VENTILATOR
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BTM
1991-11-13
EMS SINGLE USE MANUAL RESUSCITATORS
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BTM
1991-11-08
RONDEX MASKS MODELS 9015/9011/901102 MODIFIED
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BTM
1991-10-07
AMBU SILICONE RESUSCITATOR INFANT/CHILD
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BTM
1991-08-26
MODIFICATION MANUAL RESUSCITATOR (PMR 2)
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BTM
1991-08-09
MODIFIED SINGLE PATIENT USE DISP. MANUAL RESUSCIT.
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BTM
1991-08-02
MOUTH TO MASK RESUSCITATOR
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BTM
1991-07-24
VITAL SIGNS CODE BLUE ADULT MANUAL RESUSCITATOR
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BTM
1991-06-25
PRESSURE LIMITING ELBOW WITH MANOMETER PORT
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BTM
1991-06-18
MANUAL RESUSCITATOR
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BTM
1991-05-28
AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT
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BTM
1991-05-20
CPR BAG
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BTM
1991-04-17
DRESSER ARGUS P/N 1818
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BTM
1991-03-29
SINGLE USE MANUAL RESUSCITATORS
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BTM
1990-10-02
BAUMAN CPR/RESUSCITATOR
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BTM
1990-08-22
1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR
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BTM
1990-08-17
INFANT MANUAL RESUSCITATOR (PMR 2)
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BTM
1990-08-17
SINGLE PATIENT USE INFANT DISPOSABLE MANUAL RESUSC
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BTM
1990-08-17
MODIFIED SINGLE PATIENT USE DISP MAN RESUSCITATOR
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BTM
1990-08-17
MOD PURITAN BENNETT SING PATIENT DISPOS MAN RESUS
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BTM
1990-07-16
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR) INFANT
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BTM
1990-07-16
1ST RESPONSE REUSABLE MANUAL RESUSCITATOR (ADULT)
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BTM
1990-06-08
AMBU LIFE KEY AND AMBU RES-CUE KEY
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BTM
1990-05-18
LIFE AID RESUSCITATOR
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BTM
1990-05-01
PURITAN BENNETT SINGLE PATIENT USE PEEP ADAPTER
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BTM
1990-04-04
RESUSO MASK
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BTM
1990-03-30
MANUAL RESUSCITATOR
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BTM
1990-02-06
ARTEC RESPOND PULMONARY RESUSCITATOR
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BTM
1989-10-27
RESPIRONICS INFANT BAGEASY
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BTM
1989-10-13
MANUAL DISPOSABLE PULMONARY RESUSCITATOR
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BTM
1989-10-06
SINGLE PATIENT USE DISPOSABLE MANUAL RESUSCITATOR
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BTM
1989-07-24
NEOVO2R VENTILATORY
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BTM
1989-05-18
PULMONARY RESUSCITATOR, MODIFICATION
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BTM
1989-02-17
OXYGENATION CATHETER
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BTM
1988-12-16
AIRWAY-CIRCULATION EVALUATOR
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BTM
1988-11-16
ADULT RESUSCITATOR WITH MASK AND FILTER
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BTM
1988-11-16
PULMANEX TM (NEO-NATAL SIZE)
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BTM
1988-09-14
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
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BTM
1988-08-16
NONREBREATHING CIRCUIT
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BTM
1988-08-15
RES-Q 1, 2, 3, 4 AND 5
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BTM
1988-06-23
CPR BAG
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BTM
1988-06-16
RESUSCITATION BAG CONTROLLER (RBC)
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BTM
1988-04-14
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
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BTM
1988-04-14
LIFEGUARD MOUTH TO MASK RESUSCITATOR
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BTM
1988-03-04
RESUSCI PATIENT FACE SHIELD
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BTM
1988-02-29
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
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BTM
1988-02-29
RESUSCITATOR
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BTM
1988-01-22
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
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BTM
1988-01-19
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
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BTM
1988-01-19
SOLCO SILICONE RESUSCITATOR
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BTM
1987-10-26
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
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BTM
1987-09-28
MOUTH TO FACE RESUSCITATOR
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BTM
1987-04-20
MODIFIED CPREVIVER
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BTM
1987-03-09
BAUMAN CPR/RESPIRATOR
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BTM
1987-02-26
CPREVIVER
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BTM
1986-08-26
PULMANEX TM (MODIFICATION)
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BTM
1986-03-27
PULMANEX (TM)
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BTM
1986-03-06
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
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BTM
1985-11-01
PULMANEX
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BTM
1985-09-06
COMBIBAG MANUAL RESUSCITATOR
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BTM
1985-07-08
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
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BTM
1985-03-25
RESUSCITATOR, PULMONARY, MANUAL
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BTM
1985-02-26
STAT BLUE DISPOS. MANUAL RESUSCITATOR
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BTM
1984-12-17
MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
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BTM
1984-09-27
FLOW CONTROLLER
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BTM
1984-08-10
RESPIRONICS VENTEASY
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BTM
1984-07-27
LIFE-MASK INFANT RESUSCITATOR
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BTM
1984-07-06
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
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BTM
1984-04-24
FRASER HARLAKE HOPE III RESUSCITATOR
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BTM
1984-04-05
MANUAL RESUSCITATION SYSTEM
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BTM
1984-02-10
MARK III RESUSCITATOR
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BTM
1984-01-18
RESCUE MASK
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BTM
1984-01-13
FLYNN III-CHILD BAG-MASK UNIT ETC
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BTM
1983-11-29
REVIVE
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BTM
1983-09-29
FLYNN SERIES III BAG/MASK UNIT-
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BTM
1983-09-08
CODE BLUE MANUAL RESUSCITATOR
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BTM
1983-08-12
SC-603 TWIN VALVE
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BTM
1983-06-24
CPR HEARTSAVER AND BREATHOLATOR
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BTM
1983-01-21
DISPOSABLE AIRWAY ADEJUNCT
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BTM
1982-12-07
BE#1000-INSTANT ON/OFF O2 VALVE
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BTM
1982-10-28
SIEMENS-ELEMA AB AGA REVIVATOR
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BTM
1982-08-20
MODULAIDE EMERG. CARDIAC LIFE SUPP. KT
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BTM
1982-03-26
RESUSCITATION MASK
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BTM
1981-08-25
RESUSCITATION CIRCUIT
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BTM
1981-07-31
ZEE MANUAL RESUSCITATOR
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BTM
1981-02-12
DISPOSABLE BAG MASK ADEJUNCT
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BTM
1980-12-17
PMR-2 PURITAN MANUAL RESUSCITATOR
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BTM
1980-10-10
AIR VIVA II
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