ZPower Rechargeable System for Hearing Aids 9-06-00071-6

GUDID 80850034007072

Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

ZPOWER, LLC

Cochlear implant system battery pack

• Primary Device ID: 80850034007072
• NIH Device Record Key: 4ebcbfe0-fe6f-48ad-bd53-565335f73245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZPower Rechargeable System for Hearing Aids
• Version Model Number: Z202-312
• Catalog Number: 9-06-00071-6
• 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: false
• 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
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com
• Phone: 866-364-2909
• Email: support@zpowerbattery.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 11 KiloPascal and 0 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	80850034007072 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-31

On-Brand Devices [ZPower Rechargeable System for Hearing Aids]

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• 10811204030215: Charger for ZPower Rechargeable System for Hearing Aids
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• 00811204030195: Charger for ZPower Rechargeable System for Hearing Aids
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• 00811204030164: Charger for ZPower Rechargeable System for Hearing Aids
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• 00811204030126: Contains Charger (00811204030171) and two battery assemblies for ZPower Rechargeable System for
• 00811204030119: Contains Charger (00811204030164) and two battery assemblies for ZPower Rechargeable System for
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• 10850034007660: Battery Door Module for ZPower Rechargeable System for Hearing Aids
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• 00850034007618: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007441), 2 Battery
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• 10850034007509: Charger for ZPower Rechargeable System for Hearing Aids
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• 10850034007448: Charger for ZPower Rechargeable System for Hearing Aids
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• 00850034007410: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007502), 2 Battery
• 00850034007380: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007441), 2 Battery
• 00850034007359: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007335: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery
• 00850034007328: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 00850034007304: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery
• 00850034007212: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007205), 2 Battery
• 00850034007205: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007199: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 00850034007175: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007168), 2 Battery
• 00850034007168: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007151: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 00850034007090: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007083), 2 Battery
• 00850034007083: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007076: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 00850034007069: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007052), 2 Battery
• 00850034007052: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007045: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 00850034007021: ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007014), 2 Battery
• 00850034007014: Charger for ZPower Rechargeable System for Hearing Aids
• 00850034007007: Battery Door Module for ZPower Rechargeable System for Hearing Aids
• 80850034007195: Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)
• 80850034007157: Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)
• 80850034007072: Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)
• 80850034007003: Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)
• 00811204030577: Charger for ZPower Rechargeable System for Hearing Aids