S-CATH M Esophageal Temperature Probe

GUDID 10851498007111

CIRCA SCIENTIFIC, LLC

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 10851498007111
• NIH Device Record Key: 4d1c200d-6e64-4af4-98e3-53a1d4212bb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S-CATH M Esophageal Temperature Probe
• Version Model Number: CS-21EP
• 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: false
• Expiration Date: true
• 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	10851498007111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200943

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-01
• Device Publish Date: 2022-01-24

Devices Manufactured by CIRCA SCIENTIFIC, LLC

• 00851498007145 - CIRCA Temperature Monitoring System: 2023-07-10
• 00851498007152 - CIRCA Temperature Monitoring System: 2023-07-10
• 00851498007169 - CIRCA Temperature Cable: 2023-07-10
• 00851498007176 - CIRCA Temperature Standard: 2023-07-10
• 10851498007081 - MATRIX12 Esophageal Temperature Probe: 2023-07-10
• 10851498007135 - MATRIX12 M Esophageal Temperature Probe: 2023-07-10
• 10860237000221 - S-CATH™ Esophageal Temperature Probe: 2023-07-03
• 00860237000293 - S-CATH M Mapping Interconnect Cable: 2022-03-25