AccessGUDID - DEVICE: Battery for Optune Lua (07290107983150)

GUDID

Device Identifier (DI) Information

Brand Name: Battery for Optune Lua
Version or Model: IBH9200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IBH9200US
Company Name: Novocure GmbH

Primary DI Number: 07290107983150
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 486647295 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58847	Alternating electric field antimitotic cancer treatment system generator	A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGZ	Electrical Tumor Treatment Fields
SDA	Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H180002	000
H180002	001
H180002	002
P230042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5448da59-4003-403d-bbb2-9688a5330c89
Public Version Date: February 27, 2025
Public Version Number: 3
DI Record Publish Date: September 18, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-855-281-9301
Email: support@novocure.com

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