CIRCA Temperature Monitoring System

GUDID 00851498007077

CIRCA SCIENTIFIC, LLC

Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered Continuous electronic patient thermometer, line-powered

• Primary Device ID: 00851498007077
• NIH Device Record Key: d4b92b93-44b6-4663-9c55-78e94e2debb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIRCA Temperature Monitoring System
• Version Model Number: CS-1000 (S/W Version 2.1)
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	00851498007077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112376

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2017-07-24

On-Brand Devices [CIRCA Temperature Monitoring System]

• 00851498007077: CS-1000 (S/W Version 2.1)
• 00851498007046: CS-1000
• 00851498007121: CS-1000
• 00851498007152: CS-1000 (SW Ver 3.0)
• 00851498007145: CS-1000 (SW Ver 2.1, MATRIX12)