Iradimed

FDA UDI

Class II (US FDA UDI)

by Iradimed Corporation

Identity

Trade Name: Iradimed FDA UDI
Generic Name: Pulse oximeter probe, single-use FDA UDI
Device Name: SpO2 Disposable Applicator, Infant FDA UDI
Model / Reference: 1822I-25 FDA UDI
Description: SpO2 Disposable Applicator, Infant FDA UDI

Identifiers

Catalog Number: 1822I-25 FDA UDI
Primary DI / UDI-DI: 00856038001416 FDA UDI
510(k) Number: K172200 FDA UDI
FDA Product Code: MWI FDA UDI
GMDN Term: Pulse oximeter probe, single-use 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Pulse oximeter probe, single-use

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

Similar devices

Also classified as Pulse oximeter probe, single-use.

APK — Apk Technology · Class II
Spo2 sensor — Orantech Inc. · Class IIb
MasimoSET® M-LNCS™ NeoPt SpO2 Neonatal Pulse Oximeter Adhesive Sensor — MASIMO CORPORATION · Class II
Reusable Soft SpO2 Sensor — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class IIb
M-LNCS — MASIMO CORPORATION · Class II
APK — Apk Technology · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
MasimoSET® LNCS® NeoPt Neonatal Pulse Oximeter Adhesive Sensor — MASIMO 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

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Manufacturer

Manufacturer: Iradimed Corporation

Sources (1)

FDA UDI 220d44ee-0edd-48db-a554-4915387093e4 35 fields · synced Jun 8, 2026