GUDID 04719873693740

VT•100/VT•200 Carrying Bag Carilex

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric
Primary Device ID04719873693740
NIH Device Record Key8e16fd6e-e7dc-4ec4-a351-e34c6e555ae3
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1001-8170
Company DUNS658863238
Company NameCARILEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873693740 [Primary]

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

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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