VENTLAB, LLC

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Filters

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) (6) Mask, Gas, Anesthetic (BSJ) (2) Resuscitator,Manual,Non Self-Inflating (NHK) (2)

Premarket Exempt

Clear

Ventlab - 10889483113080 Catalog Number :

Device Description : PEDIATRIC BAG, MASK W/ INFLATABLE 02 RESERVOIR, P/OFF W/MANOMETER

Device Class : 1

Duns Number: 038305402

Premarket Exempt : No

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113103 Catalog Number :

Device Description : ADULT BAG, MASK W/INFLATABLE BAG RESERVOIR, PEEP & FLEX NECK

Device Class : 1

Duns Number: 038305402

Premarket Exempt : No

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113226 Catalog Number :

Device Description : 1/4 LITER HYPER SYSTEM W/MANOMETER & 7' SALTER TUBING

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113240 Catalog Number :

Device Description : HYPERINFLATION SYS, SIZE 1&2MS

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : NHK

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113547 Catalog Number :

Device Description : PEDIATRIC BAG, D2,D3,D4 MASK W/INFLATABLE BAG 02 RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113585 Catalog Number :

Device Description : INFANT BAG W/MANOMETER,MASK & BLOW-BY

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113608 Catalog Number :

Device Description : INFANT RESUS BAG W/MANOMETER,MASK,FILTER AND FENEM

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113622 Catalog Number :

Device Description : INFANTBAG,2MASK W/CORR.TUB,PEEP&BUILT-IN MANOMETER

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113646 Catalog Number :

Device Description : SMALL ADULT RESUS W/MASK, BAG RESERV,FILTER,PEEP AND FENEM

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483113653 Catalog Number :

Device Description : SMALL ADULT RESUS, NO MASK, COLLAP RESERV

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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