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PHILIPS BIS Module

FDA UDI

Class II (US FDA UDI)

by Philips Medizin Systeme Böblingen GmbH

Identity

Trade Name
PHILIPS BIS Module FDA UDI
Generic Name
Anaesthesia depth monitor FDA UDI
Model / Reference
862293 FDA UDI

Identifiers

Catalog Number
862293 FDA UDI
Primary DI / UDI-DI
00884838021105 FDA UDI
FDA Product Code
GWQ 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Anaesthesia depth monitor

PHILIPS BIS Module by Philips Medizin Systeme Böblingen GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia depth monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Medizin Systeme Böblingen GmbH

Sources (1)

  • FDA UDI ac22eb60-a799-4f9b-a338-e87ae809c143 34 fields · synced May 30, 2026