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BluPRO®

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name
BluPRO® FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Finger probe Adult, child (20 kg or more) Finger or toe FDA UDI
Model / Reference
TL-631T3 FDA UDI
Description
Finger probe Adult, child (20 kg or more) Finger or toe FDA UDI

Identifiers

Catalog Number
TL-631T3 FDA UDI
Primary DI / UDI-DI
00841983102752 FDA UDI
FDA Product Code
MHX FDA UDI
GWF FDA UDI
DRT FDA UDI
DRG FDA UDI
GWQ FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 FDA UDI
882.1870 FDA UDI
870.2300 FDA UDI
870.2910 FDA UDI
882.1400 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Pulse oximeter probe, reusable

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, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA UDI 84c66759-4afc-4a70-a6f6-6b29655f13f5 36 fields · synced Jun 6, 2026