S-CATH Interconnect Cable

GUDID 00851498007022

CIRCA SCIENTIFIC, LLC

Continuous electronic patient thermometer, line-powered

• Primary Device ID: 00851498007022
• NIH Device Record Key: 47055059-2eb2-4438-afe6-307d2c2f90ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-CATH Interconnect Cable
• Version Model Number: CS-101
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851498007022 [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: 2016-09-22

On-Brand Devices [S-CATH Interconnect Cable]

• 00851498007022: CS-101
• 00851498007015: CS-2003