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Bis

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
BIS FDA UDI
Generic Name
Cerebral oximeter sensor, single-use FDA UDI
Device Name
Quatro Starter Kit, (1) 186-0106, (5) 186-0150-PH FDA UDI
Model / Reference
186-0150-PH FDA UDI
Description
Quatro Starter Kit, (1) 186-0106, (5) 186-0150-PH FDA UDI

Identifiers

Primary DI / UDI-DI
10884521657823 FDA UDI
510(k) Number
K093183 FDA UDI
K143506 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Cerebral oximeter sensor, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cerebral oximeter sensor, single-use

Bis 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

K093183 also covers:

K143506 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 9c314f8a-032a-43fc-8878-28ec713349b7 36 fields · synced May 30, 2026