FDA.reportPublic FDA data

VersaTech Bariatric 1100 ULB+

Primary DI
07540161720063
Brand
VersaTech Bariatric 1100 ULB+
Company
Usine Rotec Inc
Model
V11ULB+-NA-1000
Device description
VersaTech 1100 ULB+ Bariatric bed WITH SCALE
Published
2026-04-28
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
07540161720063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161720063075401617200637540161720063

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
245707815
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
07540161720056VersaTech Bariatric 1100 ULB+ V11ULB+-NA-10102026-04-28
07540161720070VersaTech Bariatric 1100 ULB+ V11ULB+-NA-11102026-04-28
07540161720117VersaTech Med-Surg 600 ULB+ V6ULB+-NA-10002026-04-28
07540161720124VersaTech Med-Surg 600 ULB+ V6ULB+-NA-10102026-04-28
07540161720155VersaTech Med-Surg XL 700 ULB+ V7ULB+-NA-10002026-04-28
07540161720162VersaTech Med-Surg XL 700 ULB+ V7ULB+-NA-10102026-04-28
07540161720193VersaTech Med-Surg XL 700 ULB+ V7ULB+-NA-11102026-04-28
B303D040VersaTech 1100 ULBV11ULB+-xx-10002025-04-11
B303D041VersaTech 1100 ULB+V11ULB+-xx-10102025-04-11
B303D042VersaTech 1100 ULB+V11ULB+-xx-11102025-04-11
B303E030VersaTech 600 ULBV6ULB+-xx-10002025-04-11
B303E031VersaTech 600 ULB+V6ULB+-xx-10102025-04-11
B303E040VersaTech 700 ULBV7ULB+-xx-10002025-04-11
B303E041VersaTech 700 ULB+V7ULB+-xx-10102025-04-11
B303E042VersaTech 700 ULB+V7ULB+-xx-11102025-04-11
B303B0100MultiTech ULBMTULB2021-07-05
B303D0300VersaTech 1100 ULBV11ULB2021-07-05
B303E0200VersaTech 600 ULBV600ULB2021-07-05
B303F0100VersaTech LBVLB2021-07-05
B303A0000Multitech 2.0MT2.02017-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161720056VersaTech 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
00817492013100Direct SupplyHoffmann NOA Medical Industries, LLCOSI2023-01-06
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