GUDID 04713616091305

Cari Chair P.U. Global Carilex

CARILEX MEDICAL, INC.

Alternating-pressure chair cushion, reusable
Primary Device ID04713616091305
NIH Device Record Keydd8ee0d4-e2a2-456a-ab97-6dade5c867ca
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2303-3012
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
GS104713616091305 [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.

04719873696901 - NA2024-06-28 TheraFlo 9 M-set 36" x 80" WDTX Carilex
14719873696915 - NA2024-06-28 TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p
04719873696925 - NA2024-06-28 TheraFlo 9 M-set 42" x 80" DTX Carilex
14719873696939 - NA2024-06-28 TheraFlo 9 Cover 42" x 80" DTX Carilex-1p
04719873696949 - NA2024-06-28 FIT M-Set 36" x 80" VTX Carilex
04719873696956 - NA2024-06-28 FIT M-Set 36" x 80" WDTX Carilex
04719873696963 - NA2024-06-28 FIT M-set 36" x 80" QLT Carilex
04719873696970 - NA2024-06-28 FIT M-Set 42" x 80" VTX Carilex

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