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: 4000-0107-01 FDA UDI

Identifiers

Primary DI / UDI-DI: 15019517154313 FDA UDI
510(k) Number: K111386 FDA UDI
FDA Product Code: FRN FDA UDI
MRZ 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

Yes

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional 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

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI 153648f6-7757-4217-baaf-a97a126e8e20 33 fields · synced Jun 8, 2026