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TruLink

FDA UDI

Class II (US FDA UDI)

by Osi Optoelectronics, Inc.

Identity

Trade Name
TruLink FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
SpO2 Finger Sensor Reusable - Adult FDA UDI
Model / Reference
015-0660-00 FDA UDI
Description
SpO2 Finger Sensor Reusable - Adult FDA UDI

Identifiers

Catalog Number
21-00816 FDA UDI
Primary DI / UDI-DI
00859998006439 FDA UDI
510(k) Number
K030952 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Pulse oximeter probe, reusable 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

TruLink by Osi Optoelectronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K030952 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osi Optoelectronics, Inc.

Sources (1)

  • FDA UDI afb1373d-9d1c-42b2-b5cc-b7e60809366e 35 fields · synced May 30, 2026