GUDID 04719873698349

AVA Cure M-set 36'' × 80'' TDX Carilex

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system
Primary Device ID04719873698349
NIH Device Record Key749d3b5c-388e-40f7-885e-5f4f15237a11
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2109-2010
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
GS104719873698349 [Primary]

FDA Product Code

FNMMattress, Air Flotation, Alternating Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-28
Device Publish Date2025-08-20

Devices Manufactured by CARILEX MEDICAL, INC.

14719873698216 - NA2025-08-28 CariRaise Cover 20" x 75" TDX Carilex-1p
04719873698332 - NA2025-08-28 AVA Cure P.U. US Carilex
04719873698349 - NA2025-08-28AVA Cure M-set 36'' × 80'' TDX Carilex
04719873698349 - NA2025-08-28 AVA Cure M-set 36'' × 80'' TDX Carilex
04719873698356 - NA2025-08-28 AVA Cure M-set 42'' × 80'' TDX Carilex
04719873698363 - NA2025-08-28 AVA Cure M-set 36'' × 84'' TDX Carilex
04719873698370 - NA2025-08-28 AVA Cure M-set 42'' × 84'' TDX Carilex
14719873698384 - NA2025-08-28 AVA Cure Cover 36'' × 80'' TDX Carilex-1p
14719873698391 - NA2025-08-28 AVA Cure Cover 42'' × 80'' TDX Carilex-1p

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