FDA.reportPublic FDA data

Accessories

Primary DI
00810055882939
Brand
Accessories
Company
JOERNS HEALTHCARE, LLC
Model
XTB-0842
Catalog number
XTB-0842
Device description
PREVAMATT 8X42 INCH FOOTEND BOLSTER
Published
2022-04-07
Public version status
New
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
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
00810055882939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055882939008100558829398100558829390810055882939

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
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
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
00810055884407ProMatt PlusPMPE3480SZBAPMPE3480SZBA2025-05-08
00810055884384ProMatt PlusPMP3680SZBA-CPMP3680SZBA-C2025-04-24
00810055884391ProMatt PlusPMP4280SZBA-C2025-04-24
00810055884377ProMatt PlusPMPE3482SZBADTPMPE3482SZBADT2025-03-04
00810055884223Panacea 1000PAN1000-FLEX-RILQSPAN1000-FLEX-RILQS2024-11-20
00810055884216SlingsNA257052024-05-30
00810055884155Gel FoamPVEN-3576FLNA2SZP2024-03-25
00810055884162Gel FoamPVEN-3580FLNA2SZP2024-03-25
00810055884179Gel FoamPVEN-3584FLNA2SZP2024-03-25

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
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
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03