Baha 95460

GUDID 09321502036399

Cochlear Baha Control App for Android

Cochlear Bone Anchored Solutions AB

Hearing aid/implant system remote control

• Primary Device ID: 09321502036399
• NIH Device Record Key: 65375bf5-980e-4dd5-bcb0-300d55cdf43d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha
• Version Model Number: 95460
• Catalog Number: 95460
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502036399 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153245

FDA Product Code

• LXB: Hearing aid, bone 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: 4
• Public Version Date: 2020-12-21
• Device Publish Date: 2016-10-24

On-Brand Devices [Baha]

• 09321502043939: BIA310 Implant 4mm with 8mm abutment
• 09321502043922: BIA310 Implant 4mm with 10mm abutment
• 09321502043915: BIA310 Implant 4mm with 12mm abutment
• 09321502043885: BA310 Abutment 10mm
• 09321502043878: BA310 Abutment 12mm
• 09321502043861: BA310 Abutment 8mm
• 09321502043908: BIA310 Implant 4 mm with 14mm abutment
• 09321502043892: BIA310 Implant 4mm with 6mm abutment
• 09321502045001: Baha SoundArc Fun Colour Kit
• 09321502044998: Baha SoundArc Hair Matching Colour Kit
• 09321502034029: Indicator for Baha 5 SuperPower, Connect System
• 09321502043854: BA310 Abutment 14 mm
• 09321502043847: BA310 Abutment 6 mm
• 09321502040327: Baha SoundArc Colour Kit
• 09321502036368: Indicator for Baha 5 SuperPower, Baha Attract System
• 09321502036351: Indicator for Baha 5 SuperPower, Baha Connect System
• 09321502043755: Baha SoundArc Extra Small
• 09321502040907: Baha SoundArc Connector disc
• 09321502040891: Baha SoundArc Extra Large
• 09321502040884: Baha SoundArc Large
• 09321502040877: Baha SoundArc Medium
• 09321502040310: Baha SoundArc Small
• 09321502040242: Inner Case Baha 4/BP100 (Spare part)
• 09321502040167: Screwdriver for Tamperproof
• 09321502035712: BP100 & Baha 4 Tamperproof battery door Sky Blue
• 09321502035705: BP100 & Baha 4 Tamperproof battery door Peony Pink
• 09321502034067: Colour Cover, Maize (3 pcs)
• 09321502033978: Baha 5 SuperPower Fitting adaptor
• 09321502033428: Colour cover, Copper (3 pcs)
• 09321502033411: Colour cover, Silver (3 pcs)
• 09321502033404: Colour cover, Brown (3 pcs)
• 09321502033398: Colour cover, Blonde (3 pcs)
• 09321502033275: Baha Programming cable CS44 long red
• 09321502033268: Baha Programming cable CS44 long blue
• 09321502033251: Baha Programming cable CS44 short red
• 09321502033244: Baha Programming cable CS44 short blue
• 09321502033206: Baha Softband soft pad
• 09321502033190: Baha Softband bilateral, Jungle
• 09321502033183: Baha Softband bilateral, Red
• 09321502033176: Baha Softband bilateral, Blonde
• 09321502033169: Baha Softband bilateral, Black
• 09321502033152: Baha Softband bilateral, Brown
• 09321502033145: Baha Softband bilateral, Dark blue
• 09321502033138: Baha Softband bilateral, Light blue
• 09321502033121: Baha Softband bilateral, Pink
• 09321502033114: Baha Softband unilateral, Jungle
• 09321502033107: Baha Softband unilateral, Red
• 09321502033091: Baha Softband unilateral, Blonde
• 09321502033084: Baha Softband unilateral, Black
• 09321502033077: Baha Softband unilateral, Brown