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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
Multi-site probe Adults, child (3 kg or more) FDA UDI
Model / Reference
TL-220T FDA UDI
Description
Multi-site probe Adults, child (3 kg or more) FDA UDI

Identifiers

Catalog Number
TL-220T-A1 FDA UDI
Primary DI / UDI-DI
04931921019696 FDA UDI
FDA Product Code
GWF FDA UDI
OLT FDA UDI
OLV FDA UDI
GWQ FDA UDI
MHX FDA UDI
DRG FDA UDI
DRT FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

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 488303fc-f914-43be-bb1d-91917e1da722 36 fields · synced Jun 8, 2026