CARILEX MEDICAL, INC.

Address:No. 77, Keji 1st Rd.,Guishan District Taoyuan,TW

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bottle, Collection, Vacuum (KDQ) (5) Negative Pressure Wound Therapy Powered Suction Pump (OMP) (2)

Premarket Exempt

No Yes

Clear

NA - 04719873695423 Catalog Number :

Device Description : Canister for VT•100 - 500ml luer lock

Device Class :

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

NA - 04719873695508 Catalog Number :

Device Description : Canister for VT•100 - 300ml lock NX

Device Class :

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

NA - 04719873695539 Catalog Number :

Device Description : Canister for VT•100 - 500ml lock NX

Device Class :

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

NA - 04719873695560 Catalog Number :

Device Description : Canister for VT•100 - 1000ml lock NX

Device Class :

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

NA - 04719873695591 Catalog Number :

Device Description : VT Drape 2pcs pack

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

NA - 04719873695669 Catalog Number :

Device Description : Canister for VT• One - 150ml luer lock

Device Class :

Duns Number: 658863238

Premarket Exempt : Yes

Product Code : KDQ

Prescription Use : Yes

Device Count : 1

NA - 04719873695881 Catalog Number :

Device Description : VT•200 NX SYS Global Carilex

Device Class : 2

Duns Number: 658863238

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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