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Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name
Iradimed FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
SpO2 Grip Sensor Starter Pack FDA UDI
Model / Reference
1171 FDA UDI
Description
SpO2 Grip Sensor Starter Pack FDA UDI

Identifiers

Catalog Number
1171 FDA UDI
Primary DI / UDI-DI
00856038001683 FDA UDI
510(k) Number
K090087 FDA UDI
K172200 FDA UDI
FDA Product Code
MWI FDA UDI
FRN FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 FDA UDI
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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Pulse oximeter probe, reusable

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

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K090087 also covers:

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 6ab38488-a5cc-4b4a-b933-74b85f6d3654 35 fields · synced Jun 8, 2026