Compumedics SynAmps RT 9021-0002-01

GUDID 09342451001504

Package, System Unit - SynAmps RT + IMECSU-2

COMPUMEDICS LIMITED

Electroencephalograph

• Primary Device ID: 09342451001504
• NIH Device Record Key: 861fff70-b2b3-4b9f-8d57-ba650de482a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compumedics SynAmps RT
• Version Model Number: SynAmps RT
• Catalog Number: 9021-0002-01
• Company DUNS: 753750967
• Company Name: COMPUMEDICS LIMITED
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com
• Phone: 1-877-294-1346
• Email: support@compumedicsusa.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09342451001504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023771

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-27
• Device Publish Date: 2016-11-17

On-Brand Devices [Compumedics SynAmps RT]

• 09342451001580: Assembly, SynAmps RT System Unit
• 09342451001573: Package, System Unit - SynAmps RT
• 09342451001566: Assembly, SynAmps RT, 64-Channel Headbox
• 09342451001559: Package, Headbox - SynAmps RT 64-Channel
• 09342451001542: Assembly, SynAmps RT Power Unit
• 09342451001535: Package, Power Unit - SynAmps RT
• 09342451001528: SynAmps RT system module + IMECSU-2
• 09342451001511: Cable Assy - Deblock/MR Interface - SynAmps2
• 09342451001504: Package, System Unit - SynAmps RT + IMECSU-2