BluPRO®

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name: BluPRO® FDA UDI
Generic Name: Pulse oximeter probe, single-use FDA UDI
Device Name: SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable FDA UDI
Model / Reference: TL-274T3 FDA UDI
Description: SpO2 probe Child / Infant (from 3 to 20 kg) Finger or toe, disposable FDA UDI

Identifiers

Catalog Number: TL-274T3 FDA UDI
Primary DI / UDI-DI: 10841983102742 FDA UDI
FDA Product Code: DRT FDA UDI
GWQ FDA UDI
MHX FDA UDI
DRG FDA UDI
GMDN Term: Pulse oximeter probe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 FDA UDI
882.1400 FDA UDI
870.1025 FDA UDI
870.2910 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Pulse oximeter probe, single-use

BluPRO® by Nihon Kohden America, Inc. — 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nihon Kohden America, Inc.

Sources (1)

FDA UDI d3bef25e-b4fd-48ac-a736-8594a18b4738 36 fields · synced May 30, 2026