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Invos

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
INVOS FDA UDI
Generic Name
Cerebral oximeter sensor, single-use FDA UDI
Device Name
OxyAlert NIRSensor Infant/Neonatal Sensor FDA UDI
Model / Reference
IS FDA UDI
Description
OxyAlert NIRSensor Infant/Neonatal Sensor FDA UDI

Identifiers

Primary DI / UDI-DI
10884521211117 FDA UDI
510(k) Number
K091224 FDA UDI
K211561 FDA UDI
FDA Product Code
MUD FDA UDI
GMDN Term
Cerebral oximeter sensor, single-use 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

Yes

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

No

FDA UDI

Category: Cerebral oximeter sensor, single-use

Invos by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebral oximeter sensor, single-use.

Cleared under the same submission

K091224 also covers:

K211561 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI 7c83dfd5-5222-4658-8101-95c0fdf740d6 36 fields · synced May 30, 2026