GUDID 04719873695607

VT Drape 2pcs pack

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID04719873695607
NIH Device Record Key9116be9b-6009-48c4-bd9b-8e50b562aa6d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1001-8300
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 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
GS104719873695591 [Primary]
GS104719873695607 [Package]
Contains: 04719873695591
Package: [35 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.

04719873698424 - NA2025-09-17 CariChair Carry Bag(single-layer)
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.