FDA.reportPublic FDA data

Direct Supply

Primary DI
00817492013100
Brand
Direct Supply
Company
Hoffmann NOA Medical Industries, LLC
Model
1070017BEI
Device description
"BED - Bariatric Pan8000, MAH - 80""-84"" x 39""-48"" (Beige)"
Published
2023-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSIBariatric Bed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSIBariatric BedGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817492013100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817492013100008174920131008174920131000817492013100

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Regulatory Flags#

DUNS number
118483654
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
00817492013131Direct Supply7520016BEI2023-11-29
00817492013148Direct Supply70400492023-11-29
00817492013155Direct Supply70400522023-11-29
00817492013162NOA Medical Industries, LLC70400532023-11-29
00817492013179Direct Supply7520018BEI2023-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161720056VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
07540161720063VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
07540161720070VersaTech Bariatric 1100 ULB+ Usine Rotec IncOSI2026-04-28
06979878770015CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770022CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770039CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770053CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770060CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
06979878770077CostcareFujian Pacific Medical Manufacturing Co.,LtdOSI2026-03-17
B303D040VersaTech 1100 ULBUsine Rotec IncOSI2025-04-11
B303D041VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
B303D042VersaTech 1100 ULB+Usine Rotec IncOSI2025-04-11
10197344001750MEDLINEMEDLINE INDUSTRIES, INC.OSI2024-09-27
04050621100555sentida 5 xxlWISSNER-BOSSERHOFF GmbHOSI2024-08-29
04050621100609sentida sc-xl USAWISSNER-BOSSERHOFF GmbHOSI2024-08-29
04050621100616sentida sc-xxl USAWISSNER-BOSSERHOFF GmbHOSI2024-08-29
00817492013186NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00817492013193NOA Medical Industries, LLCHoffmann NOA Medical Industries, LLCOSI2024-03-11
00841447108658Invacare(R) Bariatric Heavy Duty Full Electric Bed with Rails and Mattress KitINVACARE CORPORATIONOSI2023-12-18
00841447199946INVACARE® BARIATRIC TRAPEZEINVACARE CORPORATIONOSI2023-09-21
00817492013117Direct SupplyHoffmann NOA Medical Industries, LLCOSI2023-06-09
04050621100463sentida 6-xlWISSNER-BOSSERHOFF GmbHOSI2023-01-04
04050621100456sentida 5-xlWISSNER-BOSSERHOFF GmbHOSI2022-10-28
00810055882892AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882908AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-07
00810055882564AccessoriesJOERNS HEALTHCARE, LLCOSI2022-04-05
B303D0300VersaTech 1100 ULBUsine Rotec IncOSI2021-07-05
10888277651838MedlineMEDLINE INDUSTRIES, INC.OSI2020-11-03
00815067071555PROBASICSDrive Devilbiss HealthcareOSI2020-09-07
00815067071562PROBASICSDrive Devilbiss HealthcareOSI2020-09-07