FetaLink®

GUDID 00853023006081

CERNER CORPORATION

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• Primary Device ID: 00853023006081
• NIH Device Record Key: 3130d792-6abe-4c42-b560-80463f101e3d
• Commercial Distribution Discontinuation: 2016-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: FetaLink®
• Version Model Number: FetaLink2013
• 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	00853023006081 [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: 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®]

• 00853023006081: FetaLink2013
• 00853023006043: FetaLink2014