GUDID 04713616091558

Relief Aire LAL M-set 54'' × 84'' QLT H&R

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system
Primary Device ID04713616091558
NIH Device Record Key25c2a2df-8fad-4711-ac1e-f2113ab241bb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2001-2880
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
GS104713616091558 [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 Date2021-07-06
Device Publish Date2021-06-28

Devices Manufactured by CARILEX MEDICAL, INC.

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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

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