VENTLAB, LLC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilator, Emergency, Manual (Resuscitator) (BTM) (5)

Premarket Exempt

Clear

Stat-Check - 10889483230640 Catalog Number :

Device Description : Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapte Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapter, Mask & MaxCap

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

V-Care - 10889483230657 Catalog Number :

Device Description : Pediatric Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm Pediatric Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-Off, B/V Filter, PEEP Valve & Mask

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

V-Care - 10889483230664 Catalog Number :

Device Description : V-Care Infant Resuscitator with Collapsible Accumulator, Integrated Manometer, 4 V-Care Infant Resuscitator with Collapsible Accumulator, Integrated Manometer, 40cm H2O Pop-off, B/V Filter, PEEP Valve and Mask

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

V-Care - 10889483230671 Catalog Number :

Device Description : V-Care Adult Resuscitator with Collapsible Accumulator, Integrated Manometer, B/ V-Care Adult Resuscitator with Collapsible Accumulator, Integrated Manometer, B/V Filter, PEEP

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Horizon - 10889483230688 Catalog Number :

Device Description : Adult Resuscitator with Bag Reservoir, Integrated Manometer, 40cm H20 Pop-Off, P Adult Resuscitator with Bag Reservoir, Integrated Manometer, 40cm H20 Pop-Off, PEEP Valve and Mask

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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