Portable Battery for NovoTTF-100L IBH9050US

GUDID 07290107982917

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator

• Primary Device ID: 07290107982917
• NIH Device Record Key: 8569bfe2-9196-4350-a926-6f6cdbbcadae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Battery for NovoTTF-100L
• Version Model Number: IBH9000
• Catalog Number: IBH9050US
• Company DUNS: 486647295
• Company Name: Novocure GmbH
• 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
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107982917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H180002

FDA Product Code

• QGZ: Electrical Tumor Treatment Fields

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: 2020-12-16
• Device Publish Date: 2020-12-08

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