AMGEN INC.

Address:12000 Plantside Dr.,Louisville,KY,40299,US

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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

Pump, Infusion (FRN) (4) Injector, Pen (NSC) (3) Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (ONB) (2) Syringe, Piston (FMF) (2) Introducer, Syringe Needle (KZH) (1)

Premarket Exempt

Clear

Onpro kit - 00355513192019 Catalog Number :

Device Description : On-Body Injector for Neulasta

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : KZH, NSC

Prescription Use : Yes

Device Count : 1

Repatha Pushtronex System - 00355513770019 Catalog Number :

Device Description : On-Body Infusor and Prefilled Cartridge

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Repatha Pushtronex System, sample - 00355513770910 Catalog Number :

Device Description : On-Body Infusor and Prefilled Cartridge, sample

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Enbrel 25 mg/vial Multiple-use Vial - 00358406425348 Catalog Number :

Device Description : Carton contents (4 dose trays, 1 package insert with attached Medication Guide a Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit.Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger.

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : ONB, FMF

Prescription Use : Yes

Device Count : 1

Enbrel 25 mg/vial Replacement - 00358406425911 Catalog Number :

Device Description : Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : ONB, FMF

Prescription Use : Yes

Device Count : 1

AutoTouch reusable autoinjector - 00358406470010 Catalog Number :

Device Description : AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dos AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : NSC

Prescription Use : Yes

Device Count : 1

AutoTouch Connect reusable autoinjector - 00358406480019 Catalog Number :

Device Description : AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature AutoTouch Connect reusable autoinjector with optional Bluetooth wireless feature for use with Enbrel Mini (etanercept) single-dose prefilled cartridge

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : NSC

Prescription Use : Yes

Device Count : 1

Repatha Pushtronex System - 00372511770018 Catalog Number :

Device Description : On-Body Infusor and Prefilled Cartridge

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Repatha Pushtronex System, sample - 00372511770919 Catalog Number :

Device Description : On-Body Infusor and Prefilled Cartridge, sample

Device Class : 2

Duns Number: 039976196

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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