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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
FIBER OPTIC SpO2 CABLE KIT FDA UDI
Model / Reference
1170 FDA UDI
Description
FIBER OPTIC SpO2 CABLE KIT FDA UDI

Identifiers

Catalog Number
1170 FDA UDI
Primary DI / UDI-DI
00856038001164 FDA UDI
510(k) Number
K090087 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe 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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Iradimed Corporation

Sources (1)

  • FDA UDI 2484cb2d-e116-47bb-b460-d4dcef0ee040 35 fields · synced Jun 8, 2026