NovoTTF-100L Portable Battery Rack PBR9050US

GUDID 07290107982931

Novocure GmbH

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Primary Device ID07290107982931
NIH Device Record Key009670e8-0a08-4d2c-90e2-15952e0a895c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoTTF-100L Portable Battery Rack
Version Model NumberPBR9000
Catalog NumberPBR9050US
Company DUNS486647295
Company NameNovocure GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com
Phone1-855-281-9301
Emailsupport@novocure.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107982931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QGZElectrical Tumor Treatment Fields

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-15
Device Publish Date2020-12-07

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07290107982788 - ILE Transducer Arrays Large White Connector2020-12-17
07290107982801 - Power Supply for NovoTTF-100L 2020-12-17
07290107982757 - ILE Transducer Arrays Small Black Connector2020-12-16
07290107982917 - Portable Battery for NovoTTF-100L2020-12-16
07290107982948 - Connection Cable for NovoTTF-100L2020-12-16

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