Optune Pax Battery Charger ICH9204US

GUDID 07290107987486

Novocure GmbH

Alternating electric field antimitotic cancer treatment system generator
Primary Device ID07290107987486
NIH Device Record Key957e63ae-987f-47a2-a077-429341652c3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptune Pax Battery Charger
Version Model NumberICH9100
Catalog NumberICH9204US
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 Datefalse
Expiration Datetrue
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107987486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SHCLow Electric Field Generator For Pancreatic Cancer Treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

Devices Manufactured by Novocure GmbH

07290107987462 - Connection Cable for Optune Pax2026-02-24
07290107987479 - Battery for Optune Pax2026-02-24
07290107987486 - Optune Pax Battery Charger2026-02-24
07290107987486 - Optune Pax Battery Charger2026-02-24
07290107987493 - Power Supply for Optune Pax 2026-02-24
07290107987509 - Optune Pax2026-02-24
07290107985895 - Optune HFE transducer array white 2025-06-26
07290107986236 - Battery for Optune GIO2025-03-14
07290107986373 - Connection Cable for Optune Gio2025-03-14 Connection Cable unit

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