Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name: Iradimed FDA UDI
Generic Name: Portable active medical device mount FDA UDI
Device Name: Mount, Arm, 3886 Agents Module FDA UDI
Model / Reference: 1883 FDA UDI
Description: Mount, Arm, 3886 Agents Module FDA UDI

Identifiers

Catalog Number: 1883 FDA UDI
Primary DI / UDI-DI: 00856038001669 FDA UDI
510(k) Number: K172200 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Portable active medical device mount FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Portable active medical device mount

Iradimed by Iradimed Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Portable active medical device mount.

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CIRCULAR OXYGENATOR BRACKET LARGE — Thoratec Switzerland GmbH · Class I
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class I
CONSOLE STANDOFF DISTANCE HOLDER — Thoratec Switzerland GmbH · Class II
CDI OneView™ Monitoring System — Terumo Cardiovascular Systems Corporation · Class II

Cleared under the same submission

K172200 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: Iradimed Corporation

Sources (1)

FDA UDI c88efc83-bb14-4af6-ba82-7f2312079741 35 fields · synced Jun 8, 2026