Bis

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: BIS FDA UDI
Generic Name: Anaesthesia depth monitor FDA UDI
Device Name: BISX Module,Software Version 1.15,For use with BIS Complete Monitors FDA UDI
Model / Reference: 186-0195-AMS FDA UDI
Description: BISX Module,Software Version 1.15,For use with BIS Complete Monitors FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521129832 FDA UDI
510(k) Number: K072286 FDA UDI
FDA Product Code: OLW FDA UDI
GMDN Term: Anaesthesia depth monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1400 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

Yes

FDA UDI

Category: Anaesthesia depth monitor

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

Similar devices

Also classified as Anaesthesia depth monitor.

NeuroSENSE — NEUROWAVE SYSTEMS, INC. · Class II
PHILIPS BIS Module — Philips Medizin Systeme Böblingen GmbH · Class II
BIS — Covidien LP · Class II
BIS — Covidien LP · Class II
BIS — Covidien LP · Class II
BIS — Covidien LP · Class II
BIS — Covidien LP · Class II
BIS — Covidien LP · Class II

Cleared under the same submission

K072286 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 110bc50b-aeaf-4e83-b54f-aa3c038ede62 36 fields · synced May 30, 2026