Onset

FDA UDI

Class I (US FDA UDI)

by Onpharma Company

Identity

Trade Name: Onset FDA UDI
Generic Name: Pharmaceutical fluid-dispensing system FDA UDI
Device Name: Mixing Pen FDA UDI
Model / Reference: 540-01 FDA UDI
Description: Mixing Pen FDA UDI

Identifiers

Primary DI / UDI-DI: 00860001977318 FDA UDI
FDA Product Code: KYW FDA UDI
GMDN Term: Pharmaceutical fluid-dispensing system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6430 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Pharmaceutical fluid-dispensing system

Onset by Onpharma Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pharmaceutical fluid-dispensing system.

Mixing Tips — Gc America Inc. · Class II
DianaTM Automated Drug Compounding System — ICU MEDICAL, INC. · Class II
Diana Peristaltic Pump Module, Refurbished — ICU MEDICAL, INC. · Class II
COE® Adhesive — Gc America Inc. · Class II
MULTI-AD® — B. BRAUN MEDICAL INC. · Class I
Mixing Tips — Gc America Inc. · Class II
Mixing Tips — Gc America Inc. · Class II
Mixing Tips — Gc America Inc. · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Onpharma Company

Sources (1)

FDA UDI cc03ef3c-d612-4c91-ba25-7b2e703eea1d 35 fields · synced May 31, 2026