M Zn-Air Battery Pak

GUDID 00840094426993

Silver Gray

Advanced Bionics, LLC

Cochlear implant/auditory brainstem implant battery

• Primary Device ID: 00840094426993
• NIH Device Record Key: 184bb049-cde6-4a1e-bbf2-7fc1bd48a4ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M Zn-Air Battery Pak
• Version Model Number: CI-5501-140
• Company DUNS: 803906382
• Company Name: Advanced Bionics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• 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: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094426993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960058

FDA Product Code

• MCM: Implant, Cochlear

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-18
• Device Publish Date: 2023-05-10

On-Brand Devices [M Zn-Air Battery Pak]

• 00840094493285: Lava Red
• 00840094426993: Silver Gray
• 00840094426986: Precious Pink
• 00840094426979: Chestnut
• 00840094426931: Caribbean Pirate
• 00840094413276: Resin Beige
• 00840094413214: Alpine white
• 00840094413207: Velvet Black
• 00840094413177: Majesty Purple
• 00840094413160: Sand Beige
• 00840094413153: Blue Ocean