GUDID 04713616090322

TheraFlo M-set 36'' × 80'' DTX Carilex

CARILEX MEDICAL, INC.

Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system Alternating-pressure bed mattress overlay system
Primary Device ID04713616090322
NIH Device Record Key4ec91f2b-1f7b-4cd3-8695-ab6c2770c850
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS2001-2010
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 Batchtrue
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
GS104713616090322 [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 Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by CARILEX MEDICAL, INC.

04713616090322 - NA2021-05-03TheraFlo M-set 36'' × 80'' DTX Carilex
04713616090322 - NA2021-05-03 TheraFlo M-set 36'' × 80'' DTX Carilex
04713616090179 - NA2021-03-24 VT•100/VT•200 Bed Hanger
04713616090186 - NA2021-03-24 VT•100/VT•200 IV Pole Hanger
04713616090216 - NA2021-03-24 VT•200 SYS Global Carilex
04713616090285 - NA2021-03-24 VT•100 Suitcase
04713616091343 - NA2021-03-24 VT Spiral Dressing Kit Black Lock
04713616094603 - NA2021-03-24 VT Port Set Kit
04713616094634 - NA2021-03-24 VT•100 Y-Connector

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