Bis

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name: BIS FDA UDI
Generic Name: Neurophysiologic monitoring system FDA UDI
Device Name: A2000 Monitor Pole Clamp FDA UDI
Model / Reference: 150-0037 FDA UDI
Description: A2000 Monitor Pole Clamp FDA UDI

Identifiers

Primary DI / UDI-DI: 10884521128538 FDA UDI
510(k) Number: K041670 FDA UDI
FDA Product Code: GXY FDA UDI
GMDN Term: Neurophysiologic monitoring system 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Neurophysiologic monitoring system

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

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NVM5 — Nuvasive, Inc. · Class II
SafeOp — ALPHATEC SPINE, INC. · Class II
Resident Expert Software Module — FHC, INC. · Class II

Cleared under the same submission

K041670 also covers:

BIS — Covidien LP

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 1aa36d48-5c96-4efe-a94b-3ec01bd8b4b5 35 fields · synced Jun 6, 2026