Fetal monitor

GUDID 06932562310287

Guangdong Biolight Meditech Co., Ltd.

Cardiotocograph Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor

• Primary Device ID: 06932562310287
• NIH Device Record Key: 16d54b22-3b72-44be-aff0-77869a89d936
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fetal monitor
• Version Model Number: F80
• Company DUNS: 530120146
• Company Name: Guangdong Biolight Meditech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932562310287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131941

FDA Product Code

• HGM: System, Monitoring, Perinatal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-09

On-Brand Devices [Fetal monitor]

• 06932562310294: F90
• 06932562310287: F80
• 06932562310270: F50
• 06932562310263: F30