SIMPLIVIA HEALTHCARE LTD

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

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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

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (ONB) (5)

Premarket Exempt

Clear

Chemfort Bag Adaptor SPT - 37290115921473 Catalog Number :

Device Description : Part of the Chemfort family

Device Class : 2

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard 2 CSTD IV Secondary Safety - 37290115921657 Catalog Number :

Device Description : A Chemfort CSTD Product

Device Class : 2

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 50

OnGuard2 Chemfort Closed Y Inline Set - 37290115921671 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 Y Inline Set connects to Bag Adaptor CP and to a primary set

Device Class : 2

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 70

OnGuard2 Chemfort Closed Secondary IV Set - 37290115921688 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 Secondary IV Set connects to Bag Adaptor CP and to a primary set

Device Class : 2

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 70

Catheter Adaptor - 37290115921817 Catalog Number :

Device Description : The Catheter Adaptor distal end is attached to a tubeThe Catheter Adaptor proxim The Catheter Adaptor distal end is attached to a tubeThe Catheter Adaptor proximal end is attached to OnGuard / OnGuard2 Syringe Adaptor or Syringe Adaptor Lock

Device Class : 2

Duns Number: 521161349

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 30

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