PMD-200 Single Use Sensor MEK-0002

GUDID 07290017287027

MEDASENSE BIOMETRICS LTD

Analgesia nociception index monitoring system

• Primary Device ID: 07290017287027
• NIH Device Record Key: 4f6edeac-3fcc-413f-993b-a71896cd3cf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMD-200 Single Use Sensor
• Version Model Number: MEK-0002
• Catalog Number: MEK-0002
• Company DUNS: 532646234
• Company Name: MEDASENSE BIOMETRICS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com
• Phone: 610-317-1670
• Email: info@medasense.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017287027 [Package]; Contains: 07290017287201; Package: PMD-SNS-01 [20 Units]; In Commercial Distribution
GS1	07290017287034 [Package]; Package: PMD-SNS-02 [10 Units]; In Commercial Distribution
GS1	07290017287201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210022

FDA Product Code

• QVE: Adjunctive Pain Measurement Device For Anesthesiology

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: 2023-11-23
• Device Publish Date: 2023-11-15

Devices Manufactured by MEDASENSE BIOMETRICS LTD

• 07290017287027 - PMD-200 Single Use Sensor: 2023-11-23
• 07290017287027 - PMD-200 Single Use Sensor: 2023-11-23
• 07290017287249 - PMD-200 Finger Probe: 2023-11-23
• 07290017287232 - PMD-200 System: 2023-11-23 PMD-200 monitor with NOL Nociception Level Technology