CBX LLC

Address:550 Rancheros Dr,San Marcos,CA,92069,US

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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

First Aid Kit Without Drug (OHO) (2) Valve, Non-Rebreathing (CBP) (1)

Premarket Exempt

No Yes

Clear

Emergency Rescue Mask - B859ERM1010 Catalog Number :

Device Description : It is a one-way valve that directs breathing gas flow to the patient and vents e It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Device Class : 2

Duns Number: 110960383

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

First Responder Kit - B859FRK10109 Catalog Number : FRK101

Device Description : First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile glov First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and NaCl wet wipe.

Device Class : 1

Duns Number: 110960383

Premarket Exempt : Yes

Product Code : OHO

Prescription Use : Yes

Device Count : 1

First Responder Kit - B859FRK1021 Catalog Number : FRK102

Device Description : First Responder Kit contains CPR mask, one pair of nitrile gloves, emergency she First Responder Kit contains CPR mask, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and NaCl wet wipe.

Device Class : 1

Duns Number: 110960383

Premarket Exempt : Yes

Product Code : OHO

Prescription Use : No

Device Count : 1

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