FDA.reportPublic FDA data

Accessories

Primary DI
00810055882922
Brand
Accessories
Company
JOERNS HEALTHCARE, LLC
Model
XTB-0442
Catalog number
XTB-0442
Device description
BOLSTER, FOOT, 4X42
Published
2022-04-07
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
00810055882922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055882922008100558829228100558829220810055882922

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055880126SlingsNA25705NA257052025-07-22
00810055884865Dolphin Fluid Immersion SimulationDLPH-3382OOEUJ-MDLPH-3382OOEUJ-M2025-07-10
00857268006707Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2025-07-10
00857268006851Dolphin Fluid Immersion SimulationDLPH-4882LPOOJ-MDLPH-4882LPOOJ-M2025-07-10
00857268006875Dolphin Fluid Immersion SimulationDLPH-3582OO4WJ-MDLPH-3582OO4WJ-M2025-07-10
00857268006752Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-CDLPH-1717WCOOJ-C2025-07-08
00857268006295Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-MDLPH-3582OOOOJ-M2025-07-07
00857268006257Dolphin Fluid Immersion SimulationFIS Step-deckDLPH-3588OVOOJ-M2016-09-06
00857268006417Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2016-09-02
00810055884834Panacea - DSPAN1000-FLEX-RILG2PAN1000-FLEX-RILG22025-06-18
00810055884841Panacea - DSPAN1K-FLEX-RILG2QSPAN1K-FLEX-RILG2QS2025-06-18
00810055884858Panacea - DSPAN1000-FLEX-RAHG2PAN1000-FLEX-RAHG22025-06-18
00857268006868Dolphin FISDLPP-2850CBJ-MDLPP-2850CBJ-M2025-05-29
00857268006271Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2017-08-22
00857268006424Dolphin Fluid Immersion SimulationDLPH-3582LPOOOJ-MDLPH-3582LPOOOJ-M2016-09-02
00857268006714Dolphin Fluid Immersion SimulationDLPH-4882OOOOJ-M2017-08-22
00857268006318Dolphin Fluid Immersion SimulationDLPH-4282OOOOJ-M2017-08-22
00857268006394Dolphin Fluid Immersion SimulationFIS StretcherDLPH-3176OSOOJ-P2016-09-02
00857268006400Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-C2016-09-02
00857268006455Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04