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) (9) Restraint, Protective (FMQ) (1)

Premarket Exempt

No Yes

Clear

POSEY - 10190676005755 Catalog Number : V4126V

Device Description : NOVAPLUS SELF RELEASING

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : FMQ

Prescription Use : No

Device Count : 1

POSEY - 10190676006202 Catalog Number : 8399

Device Description : CHAIR ALARM BELT

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006219 Catalog Number : 8208CB

Device Description : CANISTER BRACKET ALARM

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006240 Catalog Number : 8309CLC

Device Description : DISPOSABLE CHAIR SENSOR

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006257 Catalog Number : 8309CLC66

Device Description : 8309 CHAIR SENSOR 66 INCH

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006288 Catalog Number : 8399L

Device Description : CHAIR ALARM BELT LONG

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006295 Catalog Number : V8283

Device Description : NOVAPLUS DISP BED SENSOR

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006301 Catalog Number : V8309EL

Device Description : NOVAPLUS SENSOR, CHAIR,

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006318 Catalog Number : V8309

Device Description : NOVAPLUS SENSOR, CHAIR,

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

POSEY - 10190676006325 Catalog Number : V8345

Device Description : NOVAPLUS SITTER ELITE

Device Class : 1

Duns Number: 008503294

Premarket Exempt : Yes

Product Code : KMI

Prescription Use : No

Device Count : 1

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