Orantech

FDA UDI

Class II (US FDA UDI)

by Orantech Inc.

Identity

Trade Name: Orantech FDA UDI
Generic Name: Pulse oximeter probe, reprocessed FDA UDI
Device Name: Nihon Kohden Compatible, Pediatric Soft Tip, 0.9M FDA UDI
Model / Reference: SS-043-PS09 FDA UDI
Description: Nihon Kohden Compatible, Pediatric Soft Tip, 0.9M FDA UDI

Identifiers

Primary DI / UDI-DI: 06941691973812 FDA UDI
510(k) Number: K181270 FDA UDI
FDA Product Code: DQA FDA UDI
GMDN Term: Pulse oximeter probe, reprocessed 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reprocessed

Orantech by Orantech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Pulse oximeter probe, reprocessed.

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Pulse Oximeter — Rashman Corp. · Class II

Cleared under the same submission

K181270 also covers:

Masimo Compatible Disposable SpO2 Sensor, Neonate — CABLES AND SENSORS, LLC
Orantech — Orantech Inc.
Orantech — Orantech Inc.
Orantech — Orantech Inc.
Orantech — Orantech Inc.
Orantech — Orantech Inc.
Reusable SpO2 Sensors — Orantech Inc.

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: Orantech Inc.

Sources (1)

FDA UDI e099fbd7-c923-4c92-bb04-7e84a2c53bb5 34 fields · synced May 30, 2026