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) Nebulizer (Direct Patient Interface) (CAF) (1) Tube, Tracheal (W/Wo Connector) (BTR) (1)

Premarket Exempt

Clear

Ventlab - 10889483076637 Catalog Number :

Device Description : ADULT BAG, M5 MASK W/ INFLATABLE BAG RESERVOIR, FILTER, PEEP & MANOMETER

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076675 Catalog Number :

Device Description : MDI, Spacer, Collapsible, Fluted, Antistatic

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076897 Catalog Number :

Device Description : ADULT RESUS BAG W/POP-OFF, MASK & BAG RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483076903 Catalog Number :

Device Description : ADULT BAG, MASK W/ INFLATABLE BAG RESERVOIR & VERIFY BULB

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077078 Catalog Number :

Device Description : PEDIATRIC AIRFLOW W/FILTER, POP-OFF, BAG RESERVOIR GREEN CONN.

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077085 Catalog Number :

Device Description : PEDIATRIC AIRFLOW W/MANOMETER,POP-OFF,FILTER,MASK & PEEP

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077092 Catalog Number :

Device Description : INFANT BAG W/FILTER,STAT-CHECK, MASK & BAG RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077108 Catalog Number :

Device Description : INFANT RESUS W/MANOMETER,CORRUGATED RESERVOIR & 2 MASKS

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077115 Catalog Number :

Device Description : INFANT RESUS W/MANOMETER,FILTER, BAG RESERVOIR,2MASKS & BLOW BYE

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483077139 Catalog Number :

Device Description : SM ADULT AIRFLOW BAG, MASK W/INFLATABLE BAG RESERVOIR,STRAP,MANO&FENEM

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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