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Bis™

FDA UDI

Class II (US FDA UDI)

by Nihon Kohden America, Inc.

Identity

Trade Name
BIS™ FDA UDI
Generic Name
General-purpose multi-parameter bedside monitor FDA UDI
Device Name
ASPECT BISX OPTION, BSM6000 FDA UDI
Model / Reference
NK-ASPECT-BISX FDA UDI
Description
ASPECT BISX OPTION, BSM6000 FDA UDI

Identifiers

Catalog Number
NK-ASPECT-BISX FDA UDI
Primary DI / UDI-DI
00841983103506 FDA UDI
FDA Product Code
MHX FDA UDI
GMDN Term
General-purpose multi-parameter bedside monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose multi-parameter bedside monitor

Bis™ by Nihon Kohden America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose multi-parameter bedside monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nihon Kohden America, Inc.

Sources (1)

  • FDA UDI b8194754-207b-4cf1-8a84-c39b912c5985 35 fields · synced Jun 6, 2026