S-CATH™ Esophageal Temperature Probe

GUDID 30860237000218

CIRCA Scientific, Inc.

General-purpose patient temperature probe, single-use

• Primary Device ID: 30860237000218
• NIH Device Record Key: 53e566f8-5f3b-40b3-a3e8-63f2ac8b8608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-CATH™ Esophageal Temperature Probe
• Version Model Number: CS-2001 (65cm Length)
• Company DUNS: 963223222
• Company Name: CIRCA Scientific, Inc.
• 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	10860237000214 [Primary]
GS1	20860237000211 [Package]; Contains: 10860237000214; Package: [5 Units]; In Commercial Distribution
GS1	30860237000218 [Package]; Contains: 10860237000214; Package: [10 Units]; In Commercial Distribution

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: 2025-08-04
• Device Publish Date: 2016-09-23

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

• 30860237000249: CS-2001 (50cm Length)
• 30860237000232: CS-2007 (65cm Length)
• 30860237000218: CS-2001 (65cm Length)