Audina

GUDID 00810126192004

AUDINA BTE 478

Audina Hearing Instruments, Inc.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 00810126192004
• NIH Device Record Key: b93725d3-6980-442e-9a0d-a26e039c17df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Audina
• Version Model Number: BTE 478
• Company DUNS: 606310522
• Company Name: Audina Hearing Instruments, Inc.
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810126192004 [Primary]

FDA Product Code

• ESD: Hearing Aid, Air-Conduction, Prescription

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: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [Audina]

• 00810126192042: FJMM-D60
• 00810126192035: FJMM-D75
• 00810126192028: FJMM-D55
• 00810126192011: AUDINA BTE 13D2
• 00810126192004: AUDINA BTE 478
• 00810126191991: AUDINA BTE 478 PROGRAMMABLE +
• 00810126191984: AUDINA BTE D2
• 00810126191977: AUDINA BTE D275
• 00810126191960: AUDINA BTE D6 HIGH POWER
• 00810126191953: AUDINA BTE D6 PROGRAMMABLE
• 00810126191946: AUDINA BTE D2 HIGH POWER
• 00810126191939: AUDINA BTE D PROGRAMMABLE +
• 00810126191922: AUDINA BTE INTUITION 2
• 00810126191915: AUDINA BTE INTUITION 2FC
• 00810126191908: AUDINA BTE INTUITION 4
• 00810126191892: AUDINA BTE INTUITION 6
• 00810126191885: AUDINA BTE OCTANE HP 12 WHEEL
• 00810126191878: AUDINA BTE OCTANE HP 4 WHEEL
• 00810126191861: AUDINA BTE OCTANE HP 6 WHEEL
• 00810126191854: AUDINA BTE OPTI-TRIM
• 00810126191847: AUDINA BTE OCTANE HP T
• 00810126191830: AUDINA BTE SIMPLEX 2
• 00810126191823: AUDINA BTE SIMPLEX 2 PROGRAM.+
• 00810126191816: AUDINA OTE ARRO 12
• 00810126191809: AUDINA OTE ARRO 2
• 00810126191793: AUDINA OTE ARRO 6
• 00810126191786: AUDINA OTE ARRO 6 AD
• 00810126191779: AUDINA GOHEAR 1
• 00810126191762: AUDINA GOHEAR 2
• 00810126191755: AUDINA GOHEAR 3
• 00810126191748: AUDINA GOHEAR 4
• 00810126191731: AUDINA OTE INTUITION 4
• 00810126191724: AUDINA RIC ARRO 12
• 00810126191717: AUDINA RIC ARRO 2
• 00810126191700: AUDINA RIC ARRO 6
• 00810126192059: AUDINA 1/2 SHELL INTUITION 12
• 00810126192066: Audina BTE Intuition 12