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Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name
Iradimed FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
Temperature Sensor, Fiber Optic FDA UDI
Model / Reference
1851 FDA UDI
Description
Temperature Sensor, Fiber Optic FDA UDI

Identifiers

Catalog Number
1851 FDA UDI
Primary DI / UDI-DI
00856038001546 FDA UDI
510(k) Number
K172200 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
General-purpose patient temperature probe, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: General-purpose patient temperature probe, reusable

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

Similar devices

Also classified as General-purpose patient temperature probe, reusable.

Cleared under the same submission

K172200 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iradimed Corporation

Sources (1)

  • FDA UDI 5dabb452-5aec-404f-b019-e053c776c5a7 35 fields · synced Jun 8, 2026