FDA.reportPublic FDA data

TuffCare

Primary DI
04719876190277
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
T4000
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
04719876190277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876190277047198761902774719876190277

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Regulatory Flags#

DUNS number
656289451
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719876192011TuffCareALX885T2026-07-09
04719876192295TuffCare9972026-07-09
04719876190000TuffCareS9002026-07-08
04719876190017TuffCareS9702026-07-08
04719876190048TuffCareALM842T2026-07-08
04719876190055TuffCareT80362026-07-08
04719876190079TuffCareM5002026-07-08
04719876190215TuffCareALM8312026-07-08
04719876190253TuffCareW500BW2026-07-08
04719876190383TuffCareP10002026-07-08
04719876190482TuffCareALM831T42026-07-08
04719876190499TuffCareALM842T42026-07-08
04719876190512TuffCareP2702026-07-08
04719876190574TuffCareT52482026-07-08
04719876190581TuffCareT52542026-07-08
04719876190598TuffCareT52602026-07-08
04719876190932TuffCareT80422026-07-08
04719876191519TuffCareP4652026-07-08
04719876191540TuffCareP4602026-07-08
04719876191588TuffCareT70362026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190055TuffCareSHIN-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
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
00840117324541Bariatric Full Electric Home Care Bed 54"Dynarex CorporationFNL2023-12-29
08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"Dynarex CorporationFNL2022-11-21
00840117324558Dynarex Bari + Max Bariatric Full Electric Home Care Bed 54"Dynarex CorporationFNL2022-11-21
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
10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676005588POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
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
00616784040530Bariatric HD Home Care Full Electric Bed Foot Deck 48"Dynarex CorporationFNL2021-02-02