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) (7) Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (1) Mask, Gas, Anesthetic (BSJ) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

Clear

Ventlab - 10889483071564 Catalog Number :

Device Description : Adult 14ft Oral/Nasal Cannula

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483071809 Catalog Number :

Device Description : ADULT AIRFLOW RESUS W/MANOMETER

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483071816 Catalog Number :

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

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483071847 Catalog Number :

Device Description : Full Neb Kit, Neb,T, Flex Tube, 7' O2 & Mouthpiece

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483072202 Catalog Number :

Device Description : ADULT RESUS BAG W/MANOMETER,POP-OFF,MASK AND CORRUGATED TUBE RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483072233 Catalog Number :

Device Description : SMALL ADULT RESUS W/MANOMETER,FILTER,PEEP VALVE AND FENEM

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483073308 Catalog Number :

Device Description : PEDIATRIC BAG W/MANOMETER,MASK, FILTER, STRAP & FENEM

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483073346 Catalog Number :

Device Description : SMALL ADULT RESUS BAG W/MASK AND BAG RESERVOIR

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483073964 Catalog Number :

Device Description : INFANT BAG,D1&D2MASK W/12 IN CORRUGATED TUB,PEEP & MANO

Device Class : 1

Duns Number: 038305402

Premarket Exempt : No

Product Code : BSJ

Prescription Use : Yes

Device Count : 1

Ventlab - 10889483074190 Catalog Number :

Device Description : ADULT AIRFLOW, MASK W/INFLATABLE BAG RESERVOIR, MANOMETER & ACE

Device Class : 2

Duns Number: 038305402

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

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