SIMPLIVIA HEALTHCARE LTD

Address:NORTH IND. ZONE P.O.BOX 888,KIRYAT SHMONA Northern,IL

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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

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (ONB) (10)

Premarket Exempt

Clear

OnGuard Luer Lock Adaptor - 27290115921148 Catalog Number :

Device Description : The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end conne The Luer Lock Adaptor is part of the OnGuard CSTD system. The proximal end connects to female luer lock of the IV set. The OnGuard2 Syringe Adaptor / Lock connects to the Lusr Lock Adaptor port

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 100

Tevadaptor Syringe Adaptor Lock - 27290115921261 Catalog Number :

Device Description : for use with OnGuard CSTD containing Tevadaptor Drug Reconstitution and Administ for use with OnGuard CSTD containing Tevadaptor Drug Reconstitution and Administration Components

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard®2 CSTD Bag Adaptor SP - 27290115921438 Catalog Number :

Device Description : OnGuard®2 CSTD Bag Adaptor SP A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 100

OnGuard®2 CSTD Luer Lock Adaptor - 27290115921605 Catalog Number :

Device Description : OnGuard®2 CSTD Luer Lock Adaptor A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor - 27290115921612 Catalog Number :

Device Description : OnGuard®2 CSTD 20mm Vial Adaptor and 13mm Convertor A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard®2 CSTD 28mm Vial Adaptor - 27290115921629 Catalog Number :

Device Description : OnGuard®2 CSTD 28mm Vial Adaptor A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard®2 CSTD Syringe Adaptor - 27290115921636 Catalog Number :

Device Description : OnGuard®2 CSTD Syringe Adaptor A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 100

OnGuard®2 CSTD Syringe Adaptor Lock - 27290115921643 Catalog Number :

Device Description : OnGuard®2 CSTD Syringe Adaptor Lock A Chemfort CSTD Product

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 20

OnGuard2 Chemfort Bag Adaptor CP - 27290115921667 Catalog Number :

Device Description : For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Close For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration (CADM) The Bag Adaptor CP connect to Syringe Adaptor / Syringe Adaptor Lock and to CADM sets

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard2 Chemfort Closed Adaptor SP - 27290115921698 Catalog Number :

Device Description : For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Close For use with Chemfort OnGuard CSTD The product is part of OnGurd2 Chemfort Closed Administration The Closed Adaptor SP connects to Bag Adaptor CP and to a primary set

Device Class :

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 100

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