FetaLink+

GUDID 00853023006210

CERNER CORPORATION

Obstetrics information system application software

• Primary Device ID: 00853023006210
• NIH Device Record Key: af892146-c28a-41dc-947e-3be19d4ebe43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FetaLink+
• Version Model Number: FetaLink+6
• 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	00853023006210 [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: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [FetaLink+]

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