Onpro kit

FDA UDI

Class II (US FDA UDI)

by Amgen Inc.

Identity

Trade Name: Onpro kit FDA UDI
Generic Name: Autoinjector needle FDA UDI
Device Name: On-Body Injector for Neulasta FDA UDI
Model / Reference: 9002136 FDA UDI
Description: On-Body Injector for Neulasta FDA UDI

Identifiers

Primary DI / UDI-DI: 00355513192019 FDA UDI
FDA Product Code: KZH FDA UDI
NSC FDA UDI
GMDN Term: Autoinjector needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6920 FDA UDI
880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.6 Milliliter FDA UDI

Category: Autoinjector needle

Onpro kit by Amgen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Amgen Inc.

Sources (1)

FDA UDI 7e565691-733c-4525-a18a-15c78004c0a6 35 fields · synced Jun 1, 2026