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Medfusion

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Medfusion FDA UDI
Generic Name
Infusion pump medication-dosage application software FDA UDI
Device Name
67-2586-0100-01 is an electronic file. There is no packaging. FDA UDI
Model / Reference
67-2586-0100-01 FDA UDI
Description
67-2586-0100-01 is an electronic file. There is no packaging. FDA UDI

Identifiers

Primary DI / UDI-DI
15019517130928 FDA UDI
510(k) Number
K040899 FDA UDI
K111386 FDA UDI
FDA Product Code
FRN FDA UDI
MRZ FDA UDI
GMDN Term
Infusion pump medication-dosage application software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 0 Millimeter FDA UDI
Length — 0 Millimeter FDA UDI
Width — 0 Millimeter FDA UDI
Circumference — 0 Millimeter FDA UDI
Depth — 0 Millimeter FDA UDI

Category: Infusion pump medication-dosage application software

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

Similar devices

Also classified as Infusion pump medication-dosage application software.

Cleared under the same submission

K040899 also covers:

K111386 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI b1a474ab-aac5-4e15-963f-ee71108edb83 35 fields · synced May 30, 2026