FDA.reportPublic FDA data

UmanoLocation

Primary DI
00670482000814
Brand
UmanoLocation
Company
Umano Medical Inc
Model
284-0000-TRI
Catalog number
284-0000-TRI
Device description
UmanoLocation is a powered module that mounts to hospital wall or ceiling a fixed location.
Published
2024-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10670482000811PackageGS11In Commercial Distribution
20670482000818PackageGS110In Commercial Distribution
00670482000814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1067048200081110670482000811
2067048200081820670482000818
00670482000814006704820008146704820008140670482000814

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment non-clinical data monitoring softwareAn application software program intended to extract, process, and store non-clinical processing data (e.g., log of equipment usage, equipment status) from medical equipment (e.g., sterilizers/disinfectors, refrigerators) to assist process management. It is not intended for control of equipment.

Regulatory Flags#

DUNS number
249675476
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00670482001019oneNEST M303-M803508HS2FB-BIL2026-04-24
00670482001026oneNEST M303-M843508HS2FB-BIL2026-04-24
00670482001071Echo-Flex 5002903-00002026-02-18
00670482000982Umano Connect282-0002282-00022025-08-04
00670482000920ook snowFL36 ook snowFL362025-05-16
00670482000944ook cocoonFL36 ook cocoonFL362025-05-16
00670482000951ook snow ALL200-0000200-00002025-05-16
10670482000927ook snowFL36 ook snowFL362025-05-16
00670482000937ook snow MHFL36 ook snow MHFL36 ook snow MH2025-05-16
10670482000941ook cocoonFL36 ook cocoonFL362025-05-16
10670482000958ook snow ALL200-0000200-00002025-05-16
00670482000463Freedom 500FM500FM5002021-02-05
00670482000487Freedom 1000FM1000FM10002021-06-04
00670482000470Freedom 1000FM1000FM10002021-02-05
00670482000838Patient Helper 299-0100WG-TRI299-0100WG-TRI2024-09-17
00670482000845REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64511-TRIFA64511-TRI2024-09-17
00670482000852REMOVABLE PATIENT CONTROL – 2 FUNCTIONSFA64509-TRIFA64509-TRI2024-09-17
00670482000869REMOVABLE PATIENT CONTROL – 5 FUNCTIONS299-0152-TRI299-0152-TRI2024-09-17
00670482000876REMOVABLE PATIENT CONTROL – 5 FUNCTIONSFA64510-TRIFA64510-TRI2024-09-17
00670482000883REMOVABLE PATIENT CONTROL – 6 FUNCTIONS299-0151-TRI299-0151-TRI2024-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190055TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
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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
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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