S-CATH™ Esophageal Temperature Probe

GUDID 10860237000221

CIRCA SCIENTIFIC, LLC

General-purpose patient temperature probe, single-use

• Primary Device ID: 10860237000221
• NIH Device Record Key: 94455663-32e9-438b-a4eb-8e57040f6b88
• Commercial Distribution Discontinuation: 2023-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: S-CATH™ Esophageal Temperature Probe
• Version Model Number: CS-2006 (65cm Length)
• 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: true
• 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	10860237000221 [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: 4
• Public Version Date: 2023-07-03
• Device Publish Date: 2017-12-18

On-Brand Devices [S-CATH™ Esophageal Temperature Probe]

• 30860237000201: CS-27ST (Straight)
• 10860237000221: CS-2006 (65cm Length)