FetaLink 10000085

GUDID 00850017753129

Cerner Corporation

Obstetrical monitoring/analysis software

• Primary Device ID: 00850017753129
• NIH Device Record Key: 12550e57-13bd-49ae-8c62-17a8b7392756
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FetaLink
• Version Model Number: FetaLink 200
• Catalog Number: 10000085
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	00850017753129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091251

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: 2025-04-29
• Device Publish Date: 2025-04-21

Devices Manufactured by Cerner Corporation

• 00850017753129 - FetaLink: 2025-04-29
• 00850017753129 - FetaLink: 2025-04-29
• 00850017753112 - FetaLink+: 2024-06-03
• 00850017753037 - Cerner Patient Observer: 2020-12-22
• 00853023006241 - Cerner Patient Observer: 2020-02-10
• 00853023006197 - Cerner Patient Observer: 2019-10-08
• 00853023006203 - Cerner Patient Observer: 2019-10-08
• 00853023006234 - Cerner Patient Observer: 2019-10-08
• 00853023006111 - Cerner CareAware Event Management: 2019-07-12