GUDID 04713616094603

VT Port Set Kit

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID04713616094603
NIH Device Record Key85d3c7d8-ec21-4c57-8b72-97d0d089c2d7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1001-8160
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713616094597 [Primary]
GS104713616094603 [Package]
Contains: 04713616094597
Package: [15 Units]
In Commercial Distribution
GS104713616094610 [Package]
Package: [5 Units]
In Commercial Distribution

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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.

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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

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