VIVAX MEDICAL CORPORATION

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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

BED, AC-POWERED ADJUSTABLE HOSPITAL (FNL) (6) MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE (FNM) (3)

Premarket Exempt

No Yes

Clear

Soma Safe Enclosure - 00861402000407 Catalog Number :

Device Description : Canopy afixed to frame encompassing a hospital bed preventing the patient from e Canopy afixed to frame encompassing a hospital bed preventing the patient from exiting without assistance

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000414 Catalog Number :

Device Description : Frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000421 Catalog Number :

Device Description : AC powered hospital bed with affixed frame for structural support of a canopy to AC powered hospital bed with affixed frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000438 Catalog Number :

Device Description : Manual hospital bed with affixed frame for structural support of a canopy to pre Manual hospital bed with affixed frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000445 Catalog Number :

Device Description : AC powered low hosptial bed with affixed frame for structural support of a canop AC powered low hosptial bed with affixed frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000452 Catalog Number :

Device Description : Frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000469 Catalog Number :

Device Description : Frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000476 Catalog Number :

Device Description : Frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

Soma Safe Enclosure - 00861402000483 Catalog Number :

Device Description : Frame for structural support of a canopy to prevent patient from exiting bed unassisted

Device Class : 2

Duns Number: 154815062

Premarket Exempt : No

Product Code : FNL

Prescription Use : Yes

Device Count : 1

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