TEVA PHARMACEUTICAL INDUSTRIES LIMITED

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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) (6) Set, administration, intravascular (FPA) (3)

Premarket Exempt

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TEVADAPTOR® Vial Adaptor - 17298119121116 Catalog Number : MG412111

Device Description : TEVADAPTOR® 20 mm Vial Adaptor and 13mm converter for use with OnGuardTM contai TEVADAPTOR® 20 mm Vial Adaptor and 13mm converter for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 50

TEVADAPTOR® Luer Lock Adaptor - 17298119121147 Catalog Number : MG412114

Device Description : TEVADAPTOR® Luer Lock Adaptor for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 100

TEVADAPTOR® Syringe Adaptor - 17298119121185 Catalog Number : MG412118

Device Description : TEVADAPTOR® Syringe Adaptor HF for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 50

TEVADAPTOR® 28mm Vial Adaptor - 17298119121192 Catalog Number : MG412119

Device Description : TEVADAPTOR® 28mm Vial Adaptor for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 20

TEVADAPTOR® Connecting Set - 27298119121120 Catalog Number : MG412112

Device Description : TEVADAPTOR® Connecting Set for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 100

TEVADAPTOR® Spike Port Adaptor - 27298119121137 Catalog Number : MG412113

Device Description : TEVADAPTOR® Spike Port Adaptor for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : ONB

Prescription Use : No

Device Count : 100

TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site - 27298119121151 Catalog Number : MG412115

Device Description : TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 100

TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site - 27298119121168 Catalog Number : MG412116

Device Description : TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site for use with O TEVADAPTOR® Spike Port Adaptor Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 100

TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Inj. Site - 27298119121205 Catalog Number : MG412120

Device Description : TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Injection Site for u TEVADAPTOR® Secondary IV Administration Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System

Device Class :

Duns Number: 600029649

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 70

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