FDA.reportPublic FDA data

Direct Supply

Primary DI
00817492013131
Brand
Direct Supply
Company
Hoffmann NOA Medical Industries, LLC
Model
7520016BEI
Device description
ASSIST DEVICE - Pivoting, Universal (Beige)
Published
2023-11-29
Public version status
Update
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
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492013131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492013131008174920131318174920131310817492013131

GMDN Terms#

Term, Definition table
TermDefinition
BedrailA rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118483654
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817492013254Paneca Flex Care Bed1090003-02026-01-23
00817492013261Panacea Flex Care Bed w/Safety Lock1090003-12026-01-23
00817492013278Paneca Flex Care Plus Bed1090004-02026-01-23
00817492013285Panacea Flex Care Plus Bed w/Safety Lock1090004-12026-01-23
00817492013292Panacea Essential Bed1090001-02026-01-23
00817492013308Panacea Essential Bed w/ Safety Lock1090001-12026-01-23
00817492013230Panacea Essenital Plus Bed1090002-02026-01-02
00817492013247Panacea Essential Plus w/Safety Lock1090002-12026-01-02
00000081749201Direct Supply1090001-02025-10-21
00008174920100Direct Supply1090001-12025-10-21
00087492013251Panacea Essential+1090003-02026-01-02
00087492013268Panacea Essential + with Safety Lock1090003-12026-01-02
00087492013275Panacea Flex Care +1090004-02026-01-02
00087492013282Panacea Flex Care + w/Safety Lock1090004-12026-01-02
00817492013223NOA Medical Industries10550722025-06-19
00817492013148Direct Supply70400492023-11-29
00817492013155Direct Supply70400522023-11-29
00817492013162NOA Medical Industries, LLC70400532023-11-29
00817492013179Direct Supply7520018BEI2023-11-29
00817492013209NOA Medical Industries, LLC11500002024-12-04

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
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
05060405748353BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748384BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748414BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748445BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748476BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748506BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748612BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748636BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748667BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748698BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748728BananaGBUK GROUP LIMITEDIKX2025-02-28
05060405748094BananaGBUK GROUP LIMITEDIKX2024-01-24
05060405748100BananaGBUK GROUP LIMITEDIKX2024-01-24
00840117324541Bariatric Full Electric Home Care Bed 54"Dynarex CorporationFNL2023-12-29
05060405742955BananaGBUK GROUP LIMITEDIKX2023-06-02
05060405742986BananaGBUK GROUP LIMITEDIKX2023-06-02
05060405743013BananaGBUK GROUP LIMITEDIKX2023-06-02
05060405743044BananaGBUK GROUP LIMITEDIKX2023-06-02