FDA.reportPublic FDA data

MV3

Primary DI
07613327419221
Brand
MV3
Company
STRYKER CORPORATION
Model
5900
Catalog number
5900-000-001
Published
2019-08-21
Public version status
Update
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
07613327419221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327419221076133274192217613327419221

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
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447199953INVACARE® BAR600 BARIATRIC BEDINVACARE CORPORATIONOSI2026-09-21
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
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