FDA.reportPublic FDA data

Varitech 2.0

Primary DI
B303C0100
Brand
Varitech 2.0
Company
Usine Rotec Inc
Model
Varitech 2.0
Published
2016-09-22
Public version status
Update
Distribution status
Not 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
B303C0100PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

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
07540161720063VersaTech Bariatric 1100 ULB+ V11ULB+-NA-10002026-04-28
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

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Primary DI, Brand, Company table
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