Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR

GUDID 08809475370005

MAKE A WAY CO.,LTD.

Electrocardiograph, professional, single-channel

• Primary Device ID: 08809475370005
• NIH Device Record Key: 1d75df6f-da0c-4cc7-909e-b8f58330ec47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR
• Version Model Number: BBSMT01
• Company DUNS: 694219886
• Company Name: MAKE A WAY CO.,LTD.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	08809475370005 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2021-03-10
• Device Publish Date: 2017-06-13

Devices Manufactured by MAKE A WAY CO.,LTD.

• 08809475370005 - Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR: 2021-03-10
• 08809475370005 - Make a Way PREGNANT WOMEN & FETAL HEALTH MONITOR: 2021-03-10
• 08809475370012 - Make a Way ECG Monitor: 2021-03-10