ZPower Rechargeable System for Sophono 9-06-00075-4

GUDID 00850034007106

ZPower Rechargeable System for Sophono Kit Includes 1 Charger, 1 Silver-Zinc Battery, and 1 AC Adapter

ZPOWER, LLC

Noninvasive device battery charger

• Primary Device ID: 00850034007106
• NIH Device Record Key: ffeca1f1-5788-4205-8380-929dbeed8222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZPower Rechargeable System for Sophono
• Version Model Number: SZ401-00
• Catalog Number: 9-06-00075-4
• Company DUNS: 061455809
• Company Name: ZPOWER, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-364-2909
• Email: support@zpowerbattery.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034007106 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air Conduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-09-29

Devices Manufactured by ZPOWER, LLC

• 00811204030591 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007502), 2 Battery Door Modules (00850034007496),
• 00811204030621 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00811204030577), 2 Battery Door Modules (00811204030539),
• 00811204030652 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00811204030577), 2 Battery Door Modules (00811204030546),
• 00811204030683 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00811204030577), 2 Battery Door Modules (00811204030553),
• 00811204030713 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00811204030577), 2 Battery Door Modules (00811204030560),
• 00811204030744 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 Contains Charger (00850034007502) for ZPower Rechargeable System for Hearing Aids
• 00811204030768 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 Contains Charger (00811204030188) for ZPower Rechargeable System for Hearing Aids
• 00811204030287 - ZPower Rechargeable System for Hearing Aids: 2020-02-06 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00811204030577), 2 Battery Door Modules (00811204030539),