FDA.reportPublic FDA data

NA

Primary DI
04713616091312
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S2303-3022
Device description
Relief Chair P.U. Global H&R
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
IMSSupport, Head And Trunk, Wheelchair
KICCushion, Flotation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMSSupport, Head And Trunk, WheelchairPhysical Medicine1
KICCushion, FlotationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713616091312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616091312047136160913124713616091312

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658863238
Device count
1
Premarket exempt
true
Serial number
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
07540147004033Side Mount Headrest Interface PlateMotion Concepts IncIMS2026-05-19
10197344014347MEDLINEMEDLINE INDUSTRIES, INC.KIC2026-05-08
00613732114824ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114831ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114848ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114855ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114862ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114879ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114886ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114893ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114909ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114916ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114923ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114930ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114947ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114954ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114961ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114978ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
00613732114985ROHO HIGH PROFILE Single Compartment CushionRoho, Inc.KIC2026-03-09
10194484321953CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321960CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321977CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321984CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484321991CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322004CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322011CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322028CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322035CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322042CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22
10194484322059CONDORGRAINGER INTERNATIONAL, INC.IMS2025-12-22