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) (8) Mask, Gas, Anesthetic (BSJ) (2)

Premarket Exempt

Clear

Ventlab - 10889483075876 Catalog Number :

Device Description : PEDIATRIC BAG, MASK W/INFLATABLE BAG RES

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076002 Catalog Number :

Device Description : ADULT RESUS BAG W/MANOMTER,VERIFY BULD, MASK AND BAG RESERV

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076019 Catalog Number :

Device Description : AF2100MB-3

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076170 Catalog Number :

Device Description : INFANT BAG, D1,D2 MASK W/ AER RESERVOIR, PEEP & MANOMETER

Device Class : 1

Duns Number: 038305402

Premarket Exempt : No

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076194 Catalog Number :

Device Description : INFANT SAFE SPOT, MASK W/CORRUGATED RESERVOIR, MANOMETER FILTER, PEEP & 25CM

Device Class : 1

Duns Number: 038305402

Premarket Exempt : No

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076286 Catalog Number :

Device Description : PEDIATRIC BAG W/MANOMETER, FILTER, D4 MASK & BAG RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076422 Catalog Number :

Device Description : ADULT BAG W/MANOMETER,STRAP,PEEP

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076583 Catalog Number :

Device Description : ADULT RESUS W/MASK AND BAG RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076606 Catalog Number :

Device Description : ADULT AIRFLOW W/MANOMETER, NO FILTER

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076613 Catalog Number :

Device Description : ADULT W/MANOMETER,MASK, BAG RESERVOIR & STICKER

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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