Unipower

Basic Information

• Brand Name: Unipower
• Primary DI: 00817392025289
• Version / Model: B12017
• Company Name: UNIPOWER CORPORATION
• Labeler DUNS: 609162797
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 1
• Public Version Date: 2021-05-10
• Public Version Status: New
• Public Device Record Key: faa9a524-3947-4c98-b03d-f040bdbf8eb3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	870.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38558	Primary battery	A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in "IEC 60086-1 Primary batteries - Part 1: General", or the latest version of this standard.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817392025289	GS1

Premarket Submissions

Submission Number	Supplement Number
K940842	000