BECTON DICKINSON PEN LIMITED

Address:66 Waterloo Road,Macquarie Park New South Wales,AU

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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) Needle, hypodermic, single lumen (FMI) (5)

Premarket Exempt

Yes No

Clear

BD Ultra-Fine Pen Needles, 31G x 5MM Mail Order - 00382903208821 Catalog Number : 320882

Device Description : PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 90

BD Nano Ultra-Fine Pen Needles, 32G x 4MM Mail Order - 00382903208838 Catalog Number : 320883

Device Description : PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 90

Pen Needles, 31G x 8MM - 00382903209811 Catalog Number : 320981

Device Description : PEN NDL 31G 8MM 100 BX 1200 PL

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Rite Aid Pen Needles, 31G x 5MM - 00382903209828 Catalog Number : 320982

Device Description : PEN NDL 31G 5MM 100 BX 1200 PL/RITE AID

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

BD Ultra-Fine Pen Needles, 29G x 12MM - 00382903282036 Catalog Number : 328203

Device Description : PEN NDL 29GA 12.7MM 100 BX 1200 USA

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

BD PhaSeal Optima - 00382905150531 Catalog Number : 515053

Device Description : INJECTOR N35-O MULTI

Device Class : 2

Duns Number: 988402590

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O) - 00382905150562 Catalog Number : 515056

Device Description : INJECTOR LOCKING N40-O

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O) - 00382905150579 Catalog Number : 515057

Device Description : INJECTOR LOCKING N40-O MULTI

Device Class : 2

Duns Number: 988402590

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

BD PhaSeal Optima - 00382905150609 Catalog Number : 515060

Device Description : PROTECTOR P13-O

Device Class :

Duns Number: 988402590

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

BD PhaSeal Optima - 00382905150623 Catalog Number : 515062

Device Description : PROTECTOR P13-O MULTIPACK

Device Class : 2

Duns Number: 988402590

Premarket Exempt : No

Product Code : ONB

Prescription Use : Yes

Device Count : 1

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