Unitron 063-5629-01

GUDID 00698764455794

Quantum E 312 Omni

Unitron Hearing Ltd

Canal air-conduction hearing aid

• Primary Device ID: 00698764455794
• NIH Device Record Key: 04225a2c-fd98-4379-8fe2-91ff67aa6d62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unitron
• Version Model Number: 063-5629-01
• Catalog Number: 063-5629-01
• Company DUNS: 201252087
• Company Name: Unitron Hearing Ltd
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com
• Phone: +1 519 895 0100
• Email: Quality@unitron.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00698764455794 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-12

On-Brand Devices [Unitron]

• 00698764479691: Moxi Kiss Pro Espresso
• 00698764474184: Moxi Kiss E Beige
• 00698764474177: Moxi Kiss 6 Beige
• 00698764474160: Moxi Kiss 12 Beige
• 00698764474153: Moxi Kiss 20 Beige
• 00698764468442: Flex:trial Max SP Light Gray
• 00698764468435: Flex:trial Max SPm Light Gray
• 00698764468428: Flex:trial Moxi Tungsten
• 00698764468411: Flex:trial Quantum M Tungsten
• 00698764468404: Flex:trial Quantum HP Light Gray
• 00698764468398: Flex:trial Quantum S Light Gray
• 00698764468381: Max SP Flex:trial (beige)
• 00698764468374: Max SPm Flex:trial (beige)
• 00698764468367: Flex:trial Moxi Stone
• 00698764468350: Flex:trial Quantum M Beige
• 00698764468343: Flex:trial Quantum HP Beige
• 00698764468336: Flex:trial Quantum S Beige
• 00698764463829: Moxi Kiss Pro Beige
• 00698764459853: Max E SPm (stone)
• 00698764459846: Max E SPm (dark gray)
• 00698764459839: Max E SPm (pearl)
• 00698764459822: Max E SPm (transparent blue)
• 00698764459815: Max E SPm (transparent red)
• 00698764459808: Max E SPm (taupe)
• 00698764459792: Max E SPm (black)
• 00698764459785: Max E SPm (light gray)
• 00698764459778: Max E SPm (brown)
• 00698764459761: Max 6 SPm (Stone)
• 00698764459754: Max 6 SPm (pearl)
• 00698764459747: Max 6 SPm (transparent blue)
• 00698764459730: Max 6 SPm (transparent red)
• 00698764459723: Max 6 SPm (taupe)
• 00698764459716: Max 6 SPm (dark gray)
• 00698764459709: Max 6 SPm (black)
• 00698764459693: Max 6 SPm (light gray)
• 00698764459686: Max 6 SPm (brown)
• 00698764459334: Max 20 SPm (stone)
• 00698764459327: Max 20 SPm (pearl)
• 00698764459310: Max 20 SPm (transparent blue)
• 00698764459303: Max 20 SPm (transparent red)
• 00698764459297: Max 20 SPm (taupe)
• 00698764459280: Max 20 SPm (dark gray)
• 00698764459273: Max 20 SPm (black)
• 00698764459266: Max 20 SPm (light gray)
• 00698764459259: Max 20 SPm (brown)
• 00698764459242: Max E SP (pearl)
• 00698764459235: Max E SP (stone)
• 00698764459228: Max E SP (transparent blue)
• 00698764459211: Max E SP (transparent red)
• 00698764459204: Max E SP (taupe)