BTM

Product Code: BTM


Products Classified as BTM

20Ventilator, Emergency, Manual (resuscitator)Manual Emergency Ventilator.

Total Product Life Cycle (TPLC) Devices

20Ventilator, Emergency, Manual (resuscitator)Manual Emergency Ventilator.

FDA Consensus Standards

Ventilator, Emergency, Manual (Resuscitator) [36713]21 CFR §868.5915 🔎
Ventilator, Emergency, Manual (Resuscitator) [36710]21 CFR §868.5915 🔎
Ventilator, Emergency, Manual (Resuscitator) [36711]21 CFR §868.5915 🔎
Ventilator, Emergency, Manual (Resuscitator) [29432]21 CFR §868.5915 🔎

Pre-market Notifications for BTM

K212905Sotair DeviceSafe BVM Corporation
K210288Disposable Manual ResuscitatorXiamen Compower Medical Tech. Co., Ltd.
K181583Adult 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, InfaFlexicare Medical Limited
K170663Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable ManometerForemount Enterprise Co., Ltd.
K152931Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant ResuscitatorAMBU A/S
K132172NEONATALIE RESUSCITATORLAERDAL MEDICAL A/S
K112852BABI PLUS NEONATAL RESUSCITATION BAGA PLUS MEDICAL
K102824AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRICAMBU A/S
K102649NEOPOP INFANT RESUSCITATOR WITH FLOW METERNEOFORCE GROUP, INC.
K094003REVIVATORHERSILL, S.L.
K093081POCKET BVMMICROBVM SYSTEMS LTD
K082092DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVEGALEMED CORP.
K073410SAVE RESUSCITATORARTIVENT CORPORATION
K073171RESUSCITATION TIMER, MODEL L770-CPRALLIED HEALTHCARE PRODUCTS, INC.
K072021NEOPIP INFANT RESUSCITATORNEOFORCE GROUP, INC.

Global Unique Device Identification Database

00260720011537Ventilator, Emergency, Manual (Resuscitator)
20260720001440Ventilator, Emergency, Manual (Resuscitator)
20260720001433Ventilator, Emergency, Manual (Resuscitator)
20260720001426Ventilator, Emergency, Manual (Resuscitator)
20260720001419Ventilator, Emergency, Manual (Resuscitator)
20260720001327Ventilator, Emergency, Manual (Resuscitator)
20260720001310Ventilator, Emergency, Manual (Resuscitator)
20260720001303Ventilator, Emergency, Manual (Resuscitator)
20260720001297Ventilator, Emergency, Manual (Resuscitator)
20260720001266Ventilator, Emergency, Manual (Resuscitator)
20260720001259Ventilator, Emergency, Manual (Resuscitator)
20260720001242Ventilator, Emergency, Manual (Resuscitator)
20260720001235Ventilator, Emergency, Manual (Resuscitator)
20260720001211Ventilator, Emergency, Manual (Resuscitator)
20260720001198Ventilator, Emergency, Manual (Resuscitator)

Maude Adverse Events

HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTERTELEFLEX MEDICAL2020-03-16
AIRFLOWSUNMED HOLDINGS LLC.2020-03-13
MCKESSON DISPOSABLE HYPERINFLATION SYSTEM 1/2 L BAGAMBU, INC.2020-02-26
AIRFLOWSUNMED HOLDINGS, LLC.2020-02-24
AIRFLOWSUNMED HOLDINGS LLC.2020-02-07
AIRFLOWSUNMED HOLDINGS LLC.2020-02-06
AIRFLOWSUNMED HOLDINGS LLC.2020-02-06
AIRFLOWSUNMED HOLDINGS, LLC.2020-01-29
HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER &TELEFLEX MEDICAL2020-01-28
CAREFUSION PEDIATRIC RESUSCITATION BAGCAREFUSION 2200, INC.2020-01-28
AIRFLOWSUNMED HOLDINGS, LLC.2020-01-28
SPUR? II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATORAMBU A/S2020-01-16
AIRFLOWSUNMED HOLDINGS LLC.2020-01-15
HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER &TELEFLEX MEDICAL2020-01-10
MEDLINESUNMED HOLDINGS, LLC.2020-01-06
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTERTELEFLEX MEDICAL2019-10-24
AIRFLOWSUNMED HOLDINGS, LLC.2019-10-14
INFANT CPR BAGMERCURY ENTERPRISES, INC.2019-10-07
AIRFLOWSUNMED HOLDINGS LLC.2019-10-04
AIRFLOWSUNMED HOLDINGS, LLC.2019-09-27
AIRFLOWSUNMED HOLDINGS LLC.2019-09-26
AMBU SPUR IIAMBU A/S2019-09-05
AIRFLOW2019-09-03
AIRFLOWSUNMED HOLDINGS LLC.2019-08-27
BREATHTECHSUNMED HOLDINGS, LLC.2019-08-21
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETERHUDSON RCI, TELEFLEX MEDICAL2019-06-26
HUDSON MANUAL RESUSCITATOR,DURABLE CHILD W/MASTELEFLEX MEDICAL2019-06-10
AIRFLOWSUNMED HOLDINGS LLC.2019-05-28
AIRFLOWSUNMED HOLDINGS LLC.2019-05-13
AIRFLOWSUNMED HOLDINGS LLC.2019-05-13
AIRFLOWSUNMED HOLDINGS LLC.2019-04-11
HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP VTELEFLEX MEDICAL2019-03-29
HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP VTELEFLEX MEDICAL2019-03-29
AIRFLOWSUNMED HOLDINGS LLC.2019-03-26
HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTERTELEFLEX MEDICAL2019-03-26
HUDSON RCI LIFESAVER ADULT MANUAL RESUSCITATORTELEFLEX INCORPORATED2019-03-26

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