GUDID 04719873695881

VT•200 NX SYS Global Carilex

CARILEX MEDICAL, INC.

Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric
Primary Device ID04719873695881
NIH Device Record Key35b53991-7b1e-4ef1-bc31-d1f28d4ed4aa
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberS1002-0052
Company DUNS658863238
Company NameCARILEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS104719873695881 [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 Date2020-12-22
Device Publish Date2020-12-14

Devices Manufactured by CARILEX MEDICAL, INC.

04719873696857 - NA2023-12-12 VT•200 P.U. Global Med One
04719873696864 - NA2023-12-12 VT•200 SYS Global Med One
14713616094785 - NA2023-09-18 Envelop Cover 42'' × 80'' QLT-1p
04713616094764 - NA2023-09-06 Envelop M-set 42'' × 80'' QLT Carilex
04719873692972 - NA2022-08-23 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
00471987369297 - NA2022-08-01 TheraFlo 9 M-set 90 x 200cm WDTX Carilex
04719873692989 - NA2022-08-01 TheraFlo 9 M-set 107 x 200cm DTX Carilex
04719873693108 - NA2022-08-01 TheraFlo 7 & 9 Cover 90 x 200cm WDTX Carilex-1p

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