ZPower Rechargeable System for Hearing Aids

Basic Information

• Brand Name: ZPower Rechargeable System for Hearing Aids
• Primary DI: 00850034007335
• Version / Model: Z601-312
• Catalog Number: 9-06-00099-8
• Company Name: ZPOWER, LLC
• Labeler DUNS: 061455809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-08
• Public Version: 4
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 6ddecdce-1ba0-468f-9d1a-971108487f95

Device Description

ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00850034007328), 2 Silver-Zinc Batteries, and 1 AC Adapter, marked for demonstration use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
OSM	Hearing Aid, Air Conduction With Wireless Technology	Ear, Nose, Throat	874.3305	2
ESD	Hearing Aid, Air Conduction	Ear, Nose, Throat	874.3300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active
58185	Cochlear implant/auditory brainstem implant battery	An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850034007335	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Cell Size 312

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 20 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 11 – KiloPascal