Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name: Iradimed FDA UDI
Generic Name: MRI-patient physiologic monitoring system FDA UDI
Device Name: 3880 MRI Basic Monitor System + Temp & ETCO2 FDA UDI
Model / Reference: 3880-4 FDA UDI
Description: 3880 MRI Basic Monitor System + Temp & ETCO2 FDA UDI

Identifiers

Catalog Number: 3880-4 FDA UDI
Primary DI / UDI-DI: 00856038001355 FDA UDI
510(k) Number: K172200 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: MRI-patient physiologic monitoring system 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: MRI-patient physiologic monitoring system

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

Similar devices

Also classified as MRI-patient physiologic monitoring system.

MRI Patient Moitor Tesla DUO — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
MRI Patient Monitoring System Tesla M3 — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
MRI Patient Monitoring System Tesla M3 — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
Tesla M3 Remote Monitor — Mipm Mammendorfer Institut Fur Physik Und Medizin · Class II
Tesla M3 Remote Monitor — MIPM Mammendorfer Institut für Physik und Medizin GmbH · Class II
Iradimed — Iradimed Corporation · Class II
Iradimed — Iradimed Corporation · Class II
Iradimed — Iradimed 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

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

Manufacturer

Manufacturer: Iradimed Corporation

Sources (1)

FDA UDI b2ff5bb1-e1fb-4a70-92f3-f24d6a123c81 35 fields · synced Jun 8, 2026