FDA.reportPublic FDA data

SofCare

Primary DI
57613327282271
Brand
SofCare
Company
STRYKER CORPORATION
Model
2780-400-000
Catalog number
2780-400-000
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
57613327282271PackageGS15In Commercial Distribution
07613327282276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5761332728227157613327282271
07613327282276076133272822767613327282276

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
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

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