BM3/BM3 PLUS

GUDID 08809276940469

MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Bionet CO,LTD

Invasive-detection multi-parameter physiological monitor, reusable

• Primary Device ID: 08809276940469
• NIH Device Record Key: a1189f89-1967-495f-a754-2ffd2979c642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BM3/BM3 PLUS
• Version Model Number: 110327-030050
• Company DUNS: 689708212
• Company Name: Bionet CO,LTD
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809276940469 [Primary]
GS1	08809276949220 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132033

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-11

On-Brand Devices [BM3/BM3 PLUS]

• 08809276940469: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• 18809276943641: MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)