FDA.reportPublic FDA data

NA

Primary DI
04713616092708
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S2204-A040
Device description
Relief Max Cover 36'' × 80'' TDX H&R-1p
Published
2017-03-22
Public version status
Update
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
04713616093460PackageGS110Not in Commercial Distribution
14713616092705PackageGS110In Commercial Distribution
04713616092708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616093460047136160934604713616093460
1471361609270514713616092705
04713616092708047136160927084713616092708

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, 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.

Regulatory Flags#

DUNS number
658863238
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873698622NAS2003-A3002025-12-22
04719873698639NAS2003-A3102025-12-22
04719873698608NAS2003-22502025-12-22
04719873698615NAS2003-22602025-12-22
14719873698629NAS2003-A3002025-12-22
14719873698636NAS2003-A3102025-12-22
04713616090230NAS1001-20502018-12-05
04713616090247NAS1001-20602018-11-28
04713616091336NAS1001-21002021-03-16
04713616091350NAS1001-21302018-06-12
04713616091381NAS1001-21402018-06-12
04713616091411NAS1001-21502018-06-12
04713616092906NAS1001-20202018-06-12
04713616092913NAS1001-20302018-06-12
04713616094597NAS1001-81602021-03-16
04713616094627NAS1001-82002021-03-16
04719873691241NAS1001-21202018-12-05
04719873694938NAS1001-21602020-12-18
04719873694969NAS1001-21702020-12-14
04719873694990NAS1001-21802020-12-18

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