AUSTAR

GUDID 06943786081204

Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 06943786081204
• NIH Device Record Key: 6f0d6be7-8daf-4e64-8663-a20e2e2d0b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUSTAR
• Version Model Number: FHE512
• Company DUNS: 547919154
• Company Name: Austar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	06943786081204 [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: 2023-10-04
• Device Publish Date: 2023-09-26

On-Brand Devices [AUSTAR]

• 06943786080009: FHW120-W
• 06943786000526: BS05E
• 06943786081402: BS05E
• 06943786081419: FHW120-W
• 06943786001646: EP07
• 06943786001615: LS07
• 06943786001578: J707
• 06943786001554: J307
• 06943786001349: SU05U
• 06943786001134: SU05P
• 06943786000915: SU05
• 06943786000519: BS05R
• 06943786000434: BL04RD
• 06943786000045: RS13A
• 06943786004272: D-L-C2B
• 06943786004180: D-C-C2B
• 06943786004173: D-C-C2R
• 06943786004135: D-C-C1L
• 06943786083420: FH312
• 06943786080801: FH312
• 06943786083222: FH312-B
• 06943786080603: FH312-B
• 06943786083604: FH204
• 06943786081297: FHE503
• 06943786081280: FHE504
• 06943786081266: FHE506
• 06943786081259: FHE507
• 06943786081242: FHE508
• 06943786081235: FHE509
• 06943786081228: FHE510
• 06943786081211: FHE511
• 06943786081204: FHE512
• 06943786080993: FH203
• 06943786080986: FH204
• 06943786080979: FH205
• 06943786080962: FH206
• 06943786080955: FH207
• 06943786080931: FH209
• 06943786080924: FH210
• 06943786080900: FH212
• 06943786080894: FH303
• 06943786080887: FH304
• 06943786080870: FH305
• 06943786080863: FH306
• 06943786080849: FH308
• 06943786080832: FH309
• 06943786080825: FH310
• 06943786080818: FH311
• 06943786084014: FHE403
• 06943786083956: FHE409