Soma Safe Enclosure

GUDID 00861402000476

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

VIVAX MEDICAL CORPORATION

Hospital bed enclosure frame
Primary Device ID00861402000476
NIH Device Record Key61211b44-dcb4-4618-b578-f41c703884b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoma Safe Enclosure
Version Model NumberSSE 400
Company DUNS154815062
Company NameVIVAX MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com
Phone+1(203)729-0514
EmailSomasafe@vivaxmedical.com

Device Dimensions

Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch
Height75 Inch
Length93 Inch
Width39 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100861402000476 [Primary]

FDA Product Code

FNLBED, AC-POWERED ADJUSTABLE HOSPITAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-07
Device Publish Date2020-08-30

On-Brand Devices [Soma Safe Enclosure]

00861402000414Frame for structural support of a canopy to prevent patient from exiting bed unassisted
00861402000407Canopy afixed to frame encompassing a hospital bed preventing the patient from exiting without a
00861402000445AC powered low hosptial bed with affixed frame for structural support of a canopy to prevent pat
00861402000438Manual hospital bed with affixed frame for structural support of a canopy to prevent patient fro
00861402000421AC powered hospital bed with affixed frame for structural support of a canopy to prevent patient
00861402000483Frame for structural support of a canopy to prevent patient from exiting bed unassisted
00861402000476Frame for structural support of a canopy to prevent patient from exiting bed unassisted
00861402000469Frame for structural support of a canopy to prevent patient from exiting bed unassisted
00861402000452Frame for structural support of a canopy to prevent patient from exiting bed unassisted

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