FDA.reportPublic FDA data

Non-powered Bariatric Support Surface

Primary DI
07613327412949
Brand
Non-powered Bariatric Support Surface
Company
STRYKER CORPORATION
Model
2885
Catalog number
288505550001
Published
2019-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKYMATTRESS, FLOTATION THERAPY, NON-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327412949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327412949076133274129497613327412949

GMDN Terms#

Term, Definition table
TermDefinition
Basic bed mattressA large, durable, fabric case filled with a resilient material designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep. The device provides no special therapeutic effect.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius60 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
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30
07613327507997Stroke Fast PackSFP913100SFP9131002020-06-30
07613327635096InZone ISTIST345100960IST3451009602026-07-08
07613327638233Omnicurve10320150001032-015-0002024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H93383478Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-07-13
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04