FDA.reportPublic FDA data

SofCare

Primary DI
07613327175141
Brand
SofCare
Company
STRYKER CORPORATION
Model
2780-600-000
Catalog number
2780-600-000
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IOQBED, FLOTATION THERAPY, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
57613327175146PackageGS14In Commercial Distribution
07613327175141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332717514657613327175146
07613327175141076133271751417613327175141

GMDN Terms#

Term, Definition table
TermDefinition
Air-filled bed mattress overlayA static-air-inflated pad or thin mattress, usually full-body length, which is placed on top of a bed mattress to distribute an occupant's body weight over a large surface area, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00670482001019oneNEST MUmano Medical IncIOQ2026-04-24
00670482001026oneNEST MUmano Medical IncIOQ2026-04-24
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00887761007536pro+HILL-ROM, INC.IOQ2026-04-20
00887761007543pro+HILL-ROM, INC.IOQ2026-04-20
00887761976863pro+HILL-ROM, INC.IOQ2026-04-20
00887761976887pro+HILL-ROM, INC.IOQ2026-04-20
00887761007666pro+HILL-ROM, INC.IOQ2026-03-27
00887761007697pro+HILL-ROM, INC.IOQ2026-03-27
00887761007703pro+HILL-ROM, INC.IOQ2026-03-27
00887761007505pro+HILL-ROM, INC.IOQ2026-03-25
00887761007512pro+HILL-ROM, INC.IOQ2026-03-25
00887761007550pro+HILL-ROM, INC.IOQ2026-03-25
00887761007567pro+HILL-ROM, INC.IOQ2026-03-25
00887761007581pro+HILL-ROM, INC.IOQ2026-03-25
00887761007598pro+HILL-ROM, INC.IOQ2026-03-25
00887761007604pro+HILL-ROM, INC.IOQ2026-03-25
00887761007611pro+HILL-ROM, INC.IOQ2026-03-25
00887761007628pro+HILL-ROM, INC.IOQ2026-03-25
00887761007635pro+HILL-ROM, INC.IOQ2026-03-25
00887761007642pro+HILL-ROM, INC.IOQ2026-03-25
00887761007659pro+HILL-ROM, INC.IOQ2026-03-25
08592654562703Multicare XL I N E T spol. s r.o.IOQ2026-01-07
08592654550441MulticareL I N E T spol. s r.o.IOQ2025-12-22
08592654510407MulticareL I N E T spol. s r.o.IOQ2025-05-26
00817012031669K-3 AIRE-ZONEKAP MEDICALIOQ2025-04-04
M368LS900361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900421LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900481LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01