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BM3/BM3 Plus

FDA UDI

Class II (US FDA UDI)

by Bionet Company, Ltd.

Identity

Trade Name
BM3/BM3 Plus FDA UDI
Generic Name
Invasive-detection multi-parameter physiological monitor, reusable FDA UDI
Device Name
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) FDA UDI
Model / Reference
BM3/BM3 Plus FDA UDI
Description
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) FDA UDI

Identifiers

Primary DI / UDI-DI
08809276943644 FDA UDI
510(k) Number
K132033 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Invasive-detection multi-parameter physiological monitor, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Invasive-detection multi-parameter physiological monitor, reusable

BM3/BM3 Plus by Bionet Company, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Invasive-detection multi-parameter physiological monitor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bionet Company, Ltd.

Sources (1)

  • FDA UDI 25b79603-12ed-4212-a24c-dcadf738e427 34 fields · synced Jun 6, 2026