FDA.reportPublic FDA data

NA

Primary DI
04713616091237
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S2303-A030
Device description
Relief Chair Cover 180 × 50cm 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
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713616093484PackageGS110Not in Commercial Distribution
14713616091234PackageGS110In Commercial Distribution
04713616091237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616093484047136160934844713616093484
1471361609123414713616091234
04713616091237047136160912374713616091237

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure chair cushion, reusableA pad intended to be placed on the seat of a chair and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. This is a reusable device.

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
04719873697724NAS1001-10102026-08-26
04719873697731NAS1001-10202026-08-26
04719873697748NAS1001-10302026-08-26
04719873697755NAS1001-10402026-08-26
04719873697762NAS1001-10502026-08-26
04719873697779NAS1001-10602026-08-26
04719873697786NAS1001-10702026-08-26
04719873697793NAS1001-10802026-08-26
04719873697809NAS1001-10902026-08-26
04719873697816NAS1001-11002026-08-26
04719873697823NAS1001-11102026-08-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00613732113247ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113254ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113261ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113278ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113285ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113292ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113308ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113315ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113322ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113339ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113346ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113353ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113360ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113377ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113384ROHO QUADTRO SELECT HIGH PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113391ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113407ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113414ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113421ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113438ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113445ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113452ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113469ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113476ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113483ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113490ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113506ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113513ROHO QUADTRO SELECT LOW PROFILE CushionRoho, Inc.KIC2026-09-25
00613732113520ROHO QUADTRO SELECT MID PROFILE CushionRoho, Inc.KIC2026-09-25
00089904011497Action®ACTION PRODUCTS, INC.KIC2026-09-22