MATRIX12 M Esophageal Temperature Probe

GUDID 10851498007135

CIRCA SCIENTIFIC, LLC

General-purpose patient temperature probe, single-use

• Primary Device ID: 10851498007135
• NIH Device Record Key: abf0a9e3-4eee-4f9c-aa8e-fe2d997a500f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MATRIX12 M Esophageal Temperature Probe
• Version Model Number: CS-31EP
• 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	10851498007135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222311

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: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by CIRCA SCIENTIFIC, LLC

• 00851498007381 - CIRCA Temperature Monitoring System: 2024-11-08
• 10851498007197 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007203 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007210 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007227 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007234 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007241 - CardioCurve Steerable Sheath: 2024-08-09
• 10851498007258 - CardioCurve Steerable Sheath: 2024-08-09