FetaLink+

GUDID 00850017753112

Cerner Corporation

Obstetrical monitoring/analysis software

• Primary Device ID: 00850017753112
• NIH Device Record Key: 83becf5e-47e2-4167-a7e9-343b2a5545ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FetaLink+
• Version Model Number: FL+7
• Company DUNS: 042410688
• Company Name: Cerner Corporation
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017753112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121758

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: 1
• Public Version Date: 2024-06-03
• Device Publish Date: 2024-05-24

On-Brand Devices [FetaLink+]

• 00853023006166: FetaLink+5
• 00853023006210: FetaLink+6
• 00850017753112: FL+7
• 00850017753136: FL+Android1