GUDID 04713616090278

Canister for VT•100 - 500ml lock

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric
Primary Device ID04713616090278
NIH Device Record Key168cbbdb-5a8b-486a-a06a-ee72aa9f047e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1001-6020
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS104713616090278 [Package]
Contains: 04713616093613
Package: [5 Units]
In Commercial Distribution
GS104713616093613 [Primary]
GS104713616094702 [Package]
Package: [8 Units]
In Commercial Distribution
GS104719873693818 [Package]
Package: [12 Units]
In Commercial Distribution
GS114713616093610 [Package]
Contains: 04713616093613
Package: [5 Units]
In Commercial Distribution
GS124713616093617 [Package]
Contains: 14713616093610
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDQBottle, Collection, Vacuum
OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-03-31
Device Publish Date2017-03-22

Devices Manufactured by CARILEX MEDICAL, INC.

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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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