GN Hearing

GUDID 05708296169450

HI,PKX9ITE-DW-HP

Gn Hearing A/S

In-the-ear air-conduction hearing aid

• Primary Device ID: 05708296169450
• NIH Device Record Key: e3ecdfaf-a395-4648-8b34-b2ceb3c479c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GN Hearing
• Version Model Number: PKX9ITE-DW-HP
• Company DUNS: 306179227
• Company Name: Gn Hearing A/S
• Device Count: 1
• DM Exempt: false
• 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: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com
• Phone: +1-888-735-4327
• Email: consumerhelp@gnresound.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708296169450 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-19
• Device Publish Date: 2019-03-11

On-Brand Devices [GN Hearing]

• 05708296171088: HI,KS962-DRW,DEMO,LBL
• 05708296169825: USB,AUDIGY 2.4,CA
• 05708296169771: HI,KS962-DRW,LOANER,ANT
• 05708296169726: USB,AUDIGY 2.4,US
• 05708296169689: HI,LH561-DRW,STRL GRY
• 05708296169672: HI,LH561-DRW,DBR
• 05708296169665: HI,LH561-DRW,MBL
• 05708296169658: HI,PKX9MIH-W-UP
• 05708296169641: HI,PKX9MIH-W-MP
• 05708296169634: HI,PKX9MIH-W-LP
• 05708296169627: HI,PKX9MIH-W-HP
• 05708296169610: HI,PKX9MIH-UP
• 05708296169603: HI,PKX9MIH-S-UP
• 05708296169597: HI,PKX9MIH-S-MP
• 05708296169580: HI,PKX9MIH-S-LP
• 05708296169573: HI,PKX9MIH-S-HP
• 05708296169566: HI,PKX9MIH-MP
• 05708296169559: HI,PKX9MIH-LP
• 05708296169542: HI,PKX9MIH-HP
• 05708296169535: HI,PKX9ITE-W-UP
• 05708296169528: HI,PKX9ITE-W-MP
• 05708296169511: HI,PKX9ITE-W-HP
• 05708296169504: HI,PKX9ITE-UP
• 05708296169498: HI,PKX9ITE-MP
• 05708296169481: HI,PKX9ITE-HP
• 05708296169474: HI,PKX9ITE-DW-UP
• 05708296169467: HI,PKX9ITE-DW-MP
• 05708296169450: HI,PKX9ITE-DW-HP
• 05708296169443: HI,PKX9ITE-D-UP
• 05708296169436: HI,PKX9ITE-D-MP
• 05708296169429: HI,PKX9ITE-D-HP
• 05708296169412: HI,PKX9ITC-W-UP
• 05708296169405: HI,PKX9ITC-W-MP
• 05708296169399: HI,PKX9ITC-W-LP
• 05708296169382: HI,PKX9ITC-W-HP
• 05708296169375: HI,PKX9ITC-UP
• 05708296169368: HI,PKX9ITC-MP
• 05708296169351: HI,PKX9ITC-LP
• 05708296169344: HI,PKX9ITC-HP
• 05708296169337: HI,PKX9ITC-DW-UP
• 05708296169320: HI,PKX9ITC-DW-MP
• 05708296169313: HI,PKX9ITC-DW-LP
• 05708296169306: HI,PKX9ITC-DW-HP
• 05708296169290: HI,PKX9ITC-D-UP
• 05708296169283: HI,PKX9ITC-D-MP
• 05708296169276: HI,PKX9ITC-D-LP
• 05708296169269: HI,PKX9ITC-D-HP
• 05708296169252: HI,PKX9IIC
• 05708296169245: HI,PKX9CIC-UP
• 05708296169238: HI,PKX9CIC-MP