FetaLink+®

GUDID 00853023006050

CERNER CORPORATION

Obstetrics information system application software

• Primary Device ID: 00853023006050
• NIH Device Record Key: 70800a03-ed1e-4f32-8dc8-e8d914a5058d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FetaLink+®
• Version Model Number: FetaLink+3
• 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: 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	00853023006050 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-05

On-Brand Devices [FetaLink+®]

• 00853023006142: FetaLink+4
• 00853023006050: FetaLink+3