Medfusion

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Medfusion FDA UDI
Generic Name: Bedside syringe pump FDA UDI
Model / Reference: 22-0000-03 FDA UDI

Identifiers

Primary DI / UDI-DI: 15019517328622 FDA UDI
510(k) Number: K111386 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: Bedside syringe pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bedside syringe pump

Medfusion by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bedside syringe pump.

Novum IQ — Baxter Healthcare Corp · Class II
Perfusor® — B. BRAUN MEDICAL INC. · Class II
Perfusor® — B. BRAUN MEDICAL INC. · Class II
BD Alaris™ Syringe Module, Model 8110 — CareFusion 303, INC · Class II
Atlanta BioMedical Model 4100 — Atlanta BioMedical Corporation · Class II
Infusomat® — B. BRAUN MEDICAL INC. · Class II
Infusomat® — B. BRAUN MEDICAL INC. · Class II
Perfusor® — B. BRAUN MEDICAL INC. · Class II

Cleared under the same submission

K111386 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI e19e213d-7941-441e-95d7-48186bf927d6 33 fields · synced May 30, 2026