Invos

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: INVOS FDA UDI
Generic Name: Tissue saturation oximeter FDA UDI
Device Name: Adult Adjustable Field Test Device FDA UDI
Model / Reference: PMVAC-AFTD101A FDA UDI
Description: Adult Adjustable Field Test Device FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521528062 FDA UDI
510(k) Number: K091224 FDA UDI
FDA Product Code: MUD FDA UDI
GMDN Term: Tissue saturation oximeter 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

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tissue saturation oximeter

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

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Spectros T-Stat — Spectros Corporation · Class II
FORE-SIGHT ELITE® — Cas Medical Systems, Inc. · Class II
SnapshotNIR — Kent Imaging Inc · Class II

Cleared under the same submission

K091224 also covers:

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

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Manufacturer

Manufacturer: Covidien LP

Sources (1)

FDA UDI 250825b1-4c71-4c66-9eda-3d089558287a 36 fields · synced May 30, 2026