Thermode fMRI 16X16mm - including fMRI filter AS 00179

GUDID 07290103039943

TSA 2 fMRI Thermode 16x16

MEDOC LTD.

Thermotester, diagnostic

• Primary Device ID: 07290103039943
• NIH Device Record Key: 9e6ee428-99e2-48b7-8e03-e4d941de6a53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermode fMRI 16X16mm - including fMRI filter
• Version Model Number: fMRI Thermode
• Catalog Number: AS 00179
• Company DUNS: 600469191
• Company Name: MEDOC LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290103039943 [Primary]

FDA Product Code

• LQW: Test, Temperature Discrimination

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: 2023-06-28
• Device Publish Date: 2023-06-20

Devices Manufactured by MEDOC LTD.

• 07290103039011 - Medoc Main Station Software: 2023-06-28 Medoc Main Station Base Software
• 07290103039066 - CoVas: 2023-06-28 CoVAS USB Assy (for TSA-II, Q-Sense and AlgoMed)
• 07290103039073 - One Button Response Unit: 2023-06-28
• 07290103039219 - Thermode CHEPS: 2023-06-28 TSA 2 CHEPS Thermode Standard
• 07290103039233 - Q-Sense Response Unit: 2023-06-28 Q-Sense PRU (TSA)
• 07290103039240 - Q-Sense Base Assembly: 2023-06-28 Q-Sense Base Assembly
• 07290103039264 - Patient Response Unit: 2023-06-28 Patient Unit
• 07290103039653 - VSA 2 Hand Held: 2023-06-28 VSA 2 Hand Held