AccessGUDID - DEVICE: Zeller Power Battery (00860002738000)

GUDID

Device Identifier (DI) Information

Brand Name: Zeller Power Battery
Version or Model: ZP9146Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RECHARGEABLE POWER ENERGY NORTH AMERICA LLC

Primary DI Number: 00860002738000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041537926 *Terms of Use

Device Description: Zeller Power's Cardiac Science 9146-102/202/302 medical replacement battery is rated at 12V, 7.5Ah, 90 Wh. This replacement battery for Cardiac Science 9146-102/202/302 is 100% compatible.

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:	Yes
Prescription Use (Rx):	No
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?
48058	Disposable battery pack	A group of battery cells (e.g., lithium ion cells) held within a container that is sterile used to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. This device is typically designed to power cordless surgical power tools (e.g., a non-rechargeable battery-powered surgical drilling system handpiece) and is non-rechargeable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated External Defibrillators (Non-Wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfab20ad-b969-46ed-83df-250e0c5a8696
Public Version Date: April 27, 2020
Public Version Number: 1
DI Record Publish Date: April 17, 2020