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Soma Safe Enclosure

FDA UDI

Class II (US FDA UDI)

by Vivax Medical Corp.

Identity

Trade Name
Soma Safe Enclosure FDA UDI
Generic Name
Hospital bed enclosure frame FDA UDI
Device Name
Frame for structural support of a canopy to prevent patient from exiting bed unassisted FDA UDI
Model / Reference
SSE 400 FDA UDI
Description
Frame for structural support of a canopy to prevent patient from exiting bed unassisted FDA UDI

Identifiers

Primary DI / UDI-DI
00861402000476 FDA UDI
FDA Product Code
FNL FDA UDI
GMDN Term
Hospital bed enclosure frame FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5100 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 75 Inch FDA UDI
Length — 93 Inch FDA UDI
Width — 39 Inch FDA UDI

Category: Hospital bed enclosure frame

Soma Safe Enclosure by Vivax Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hospital bed enclosure frame.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vivax Medical Corp.

Sources (1)

  • FDA UDI 61211b44-dcb4-4618-b578-f41c703884b0 35 fields · synced Jun 8, 2026