Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name: Iradimed FDA UDI
Generic Name: Portable computer FDA UDI
Device Name: MRI Monitor Remote Tablet FDA UDI
Model / Reference: 3885T FDA UDI
Description: MRI Monitor Remote Tablet FDA UDI

Identifiers

Catalog Number: 3885T FDA UDI
Primary DI / UDI-DI: 00856038001201 FDA UDI
510(k) Number: K172200 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Portable computer 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Portable computer

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

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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 aa82c80d-8301-42e4-b17a-17bcb187b539 35 fields · synced Jun 8, 2026