M Standard battery

GUDID 07630016894022

Precious pink

Advanced Bionics AG

Secondary battery

• Primary Device ID: 07630016894022
• NIH Device Record Key: 75ac80fe-529f-42b7-a6a4-283c24739ed8
• Commercial Distribution Discontinuation: 2024-03-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: M Standard battery
• Version Model Number: CI-5555-250
• Company DUNS: 485262658
• Company Name: Advanced Bionics AG
• 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: true
• 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: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx
• Phone: +1(661)362-1400
• Email: xxx@xxx.xxx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630016894022 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-20
• Device Publish Date: 2022-12-12

On-Brand Devices [M Standard battery ]

• 07630016879548: Silver Gray
• 07630016879531: Chestnut
• 07630016879524: Sand Beige
• 07630016881725: Resin Beige
• 07630016879555: Velvet Black
• 07630016894046: Majesty purple
• 07630016894039: Blue ocean
• 07630016894022: Precious pink
• 07630016894015: CI-5555-190