CIRCA Temperature Cable

GUDID 00851498007169

CIRCA SCIENTIFIC, LLC

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• Primary Device ID: 00851498007169
• NIH Device Record Key: dc886bfd-bf29-4f3e-902a-1af91fd348b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIRCA Temperature Cable
• Version Model Number: CS-103
• Company DUNS: 963223222
• Company Name: CIRCA SCIENTIFIC, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851498007169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222311

FDA Product Code

• IKD: Cable, Electrode

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: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by CIRCA SCIENTIFIC, LLC

• 00851498007145 - CIRCA Temperature Monitoring System: 2023-07-10
• 00851498007152 - CIRCA Temperature Monitoring System: 2023-07-10
• 00851498007169 - CIRCA Temperature Cable: 2023-07-10
• 00851498007169 - CIRCA Temperature Cable: 2023-07-10
• 00851498007176 - CIRCA Temperature Standard: 2023-07-10
• 10851498007081 - MATRIX12 Esophageal Temperature Probe: 2023-07-10
• 10851498007135 - MATRIX12 M Esophageal Temperature Probe: 2023-07-10
• 10860237000221 - S-CATH™ Esophageal Temperature Probe: 2023-07-03
• 00860237000293 - S-CATH M Mapping Interconnect Cable: 2022-03-25