FDA.reportPublic FDA data

Soma Safe Enclosure

Primary DI
00861402000407
Brand
Soma Safe Enclosure
Company
VIVAX MEDICAL CORPORATION
Model
SSE 420
Device description
Canopy afixed to frame encompassing a hospital bed preventing the patient from exiting without assistance
Published
2017-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNLBED, AC-POWERED ADJUSTABLE HOSPITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861402000407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861402000407008614020004078614020004070861402000407

GMDN Terms#

Term, Definition table
TermDefinition
Hospital bed confinement canopyA fabric canopy intended to be affixed to a frame which encompasses a hospital bed to enclose a patient and thereby prevent the patient from exiting the bed without assistance. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height57Inch
Length94.5Inch
Width40.5Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(203)729-0514info@vivaxmedical.com

Regulatory Flags#

DUNS number
154815062
Device count
1
Combination product
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861402000452Soma Safe EnclosureSSE 4102020-08-30
00861402000469Soma Safe EnclosureSSE 410v2020-08-30
00861402000476Soma Safe EnclosureSSE 4002020-08-30
00861402000483Soma Safe EnclosureSSE 4252020-08-30
00861402000421Soma Safe EnclosureSSE 300e2020-03-11
00861402000438Soma Safe EnclosureSSE 300m2020-03-11
00861402000445Soma Safe EnclosureSSE 3102020-03-11
00861402000414Soma Safe EnclosureSSE 4502017-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190055TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190277TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190574TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190581TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190598TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190932TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191588TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191595TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191625TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876191663TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
06977918410150SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-10
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08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
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00840117324718Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54" Foot DeckDynarex CorporationFNL2022-11-21
M676MC7WSTMLB0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNL2022-11-08
10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
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10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
07613327584745Sidekick SpraySTRYKER CORPORATIONFNL2022-02-28
00840117302891Long-Term Care Bed, D100Dynarex CorporationFNL2021-02-03
00840117302907Long Term Care Bed, D200Dynarex CorporationFNL2021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low BedDynarex CorporationFNL2021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low BedDynarex CorporationFNL2021-02-03
00616784040424Bariatric Full Electric Home Care Bed Head Deck 42"Dynarex CorporationFNL2021-02-02
00616784040431Home Care BedDynarex CorporationFNL2021-02-02
00616784040523Bariatric HD Home Care Full Electric Bed, Head Deck, 48"Dynarex CorporationFNL2021-02-02