GUDID 04713616091312

Relief Chair P.U. Global H&R

CARILEX MEDICAL, INC.

Alternating-pressure chair cushion, reusable
Primary Device ID04713616091312
NIH Device Record Key567f90fc-6799-4445-bf84-4c6a2908b796
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2303-3022
Company DUNS658863238
Company NameCARILEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713616091312 [Primary]

FDA Product Code

IMSSupport, Head And Trunk, Wheelchair
KICCushion, Flotation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-30
Device Publish Date2017-03-22

Devices Manufactured by CARILEX MEDICAL, INC.

04719873698608 - NA2025-12-30 Envelop M-set 42" x 80" VTX Carilex
04719873698615 - NA2025-12-30 Envelop M-set 48" x 80" VTX Carilex
14719873698629 - NA2025-12-30 Envelop Cover 42" x 80" VTX Carilex-1p
14719873698636 - NA2025-12-30 Envelop Cover 48" x 80" VTX Carilex-1p
04719873693634 - NA2025-12-29 VT Drape and Port Set Kit S Lock
04719873693641 - NA2025-12-29 VT Drape and Port Set Kit M Lock
04719873693658 - NA2025-12-29 VT Drape and Port Set Kit L Lock
04719873698424 - NA2025-09-17 CariChair Carry Bag(single-layer)

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