Bis

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: BIS FDA UDI
Generic Name: Analytical scalp lead FDA UDI
Device Name: BIS (TM) Advance Monitor FDA UDI
Model / Reference: PMB4000ACBL FDA UDI
Description: BIS (TM) Advance Monitor FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521808317 FDA UDI
FDA Product Code: OLW FDA UDI
OLT FDA UDI
ORT FDA UDI
OMC FDA UDI
GMDN Term: Analytical scalp lead 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: Analytical scalp lead

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

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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 3ed4ecd2-c006-4a33-aec1-02511a4e13db 35 fields · synced May 30, 2026