GUDID 14719873696915

TheraFlo 9 Cover 36" x 80" WDTX Carilex-1p

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system
Primary Device ID14719873696915
NIH Device Record Key5924fc4a-d082-4891-b082-3f19969f30f5
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2001-A880
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 Batchtrue
Serial Numberfalse
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
GS104719873696918 [Primary]
GS114719873696915 [Package]
Contains: 04719873696918
Package: [10 Units]
In Commercial Distribution

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 Date2024-06-28
Device Publish Date2024-06-20

Devices Manufactured by CARILEX MEDICAL, INC.

04719873698424 - NA2025-09-17 CariChair Carry Bag(single-layer)
04719873698431 - NA2025-09-17 Dual GT M-set 85 x 200cm VTX Carilex
14719873698445 - NA2025-09-17 Dual GT Cover 85 x 200cm VTX Carilex-1p
14719873695741 - NA2025-09-15 VT Instill Port Set Kit
14719873695987 - NA2025-09-15 VT NX Port Set Kit
14719873698216 - NA2025-08-28 CariRaise Cover 20" x 75" TDX Carilex-1p
04719873698332 - NA2025-08-28 AVA Cure P.U. US Carilex
04719873698349 - NA2025-08-28 AVA Cure M-set 36'' × 80'' TDX Carilex

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.