GUDID 04719873694921

TheraFlo P.U. US 80 ~ 300 U85 H&R

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system
Primary Device ID04719873694921
NIH Device Record Key8893a47e-5532-4c4b-9de3-83ee9ed61c03
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2001-3161
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
GS104719873694921 [Primary]

FDA Product Code

IOQBed, Flotation Therapy, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-29
Device Publish Date2020-01-21

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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