S-CATH™ Esophageal Temperature Probe

GUDID 30860237000201

CIRCA SCIENTIFIC, LLC

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• Primary Device ID: 30860237000201
• NIH Device Record Key: fe1f3b7d-2fa2-4852-9291-ec5b999662ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-CATH™ Esophageal Temperature Probe
• Version Model Number: CS-27ST (Straight)
• 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	10860237000207 [Primary]
GS1	30860237000201 [Package]; Contains: 10860237000207; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-02
• Device Publish Date: 2019-03-25

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

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