Nonin

FDA UDI

Class II (US FDA UDI)

by Nonin Medical, Inc.

Identity

Trade Name: Nonin FDA UDI
Generic Name: Pulse oximeter probe, single-use FDA UDI
Device Name: Pediatric Disposable Single-Patient Use Pulse Oximeter Sensor FDA UDI
Model / Reference: 7000P FDA UDI
Description: Pediatric Disposable Single-Patient Use Pulse Oximeter Sensor FDA UDI

Identifiers

Primary DI / UDI-DI: 00849686072501 FDA UDI
510(k) Number: K093853 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse oximeter probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 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 Unsafe FDA UDI

Category: Pulse oximeter probe, single-use

Nonin by Nonin Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, single-use.

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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

K093853 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: Nonin Medical, Inc.

Sources (1)

FDA UDI e2adf3fd-4136-4a5b-8c28-99c7a01d9e9d 37 fields · synced Jun 9, 2026