POSEY PRODUCTS, 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

Monitor, Bed Patient (KMI) (4) Protector, Skin Pressure (FMP) (2) Bed, Ac-Powered Adjustable Hospital (FNL) (1) Cuff, Tracheal Tube, Inflatable (BSK) (1)

Premarket Exempt

No Yes

Clear

POSEY - 10190676006516 Catalog Number : 6218

Device Description : PROHEELX HEEL PROTECTOR

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

POSEY - 10190676006523 Catalog Number : 6218L

Device Description : PROHEELX LG HEELPROTECTOR

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : FMP

Prescription Use : No

Device Count : 1

POSEY - 10190676006547 Catalog Number : 6219

Device Description : POSEY STABILIZER WEDGE

Device Class : 2

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

POSEY - 10190676007131 Catalog Number : 8645

Device Description : SITTER ON CUE

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676007865 Catalog Number : V8374

Device Description : NOVAPLUS POSEY KEEPSAFE DELUXE

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676007926 Catalog Number : 8399LSL

Device Description : 8399 CHAIR ALARM BELT

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676007933 Catalog Number : 8399SL

Device Description : 8399 CHAIR ALARM BELT 3FT

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

Posey Cufflators Endotracheal Tube Inflator and Manometer - 10862229000202 Catalog Number :

Device Description : POSEY CUFFLATOR

Device Class : 2

Duns Number: 008503294

Premarket Exempt : No

Product Code : BSK

Prescription Use : Yes

Device Count : 1

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