Optune Porrtable Battery Charger ICH9100US

GUDID 07290107981750

NOVOCURE INC.

Alternating electric field antimitotic cancer treatment system generator

• Primary Device ID: 07290107981750
• NIH Device Record Key: e8c28e97-e02a-4f3b-b592-827a0e7f5f1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optune Porrtable Battery Charger
• Version Model Number: ICH9100
• Catalog Number: ICH9100US
• Company DUNS: 056552035
• Company Name: NOVOCURE INC.
• 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: 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: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com
• Phone: 1-855-281-9301
• Email: support@novocure.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Fragile - handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from extreme heat and sources of radiation
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107981750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100034

FDA Product Code

• NZK: Stimulator, Low Electric Field, Tumor Treatment

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: 2018-09-05
• Device Publish Date: 2018-08-05

On-Brand Devices [Optune Porrtable Battery Charger]

• 07290107981750: ICH9100
• 07290107981651: ICH9000