| Primary Device ID | B161RE3670 |
| NIH Device Record Key | e48fb040-ef48-462b-bc62-77eca8b4b054 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audioscan Probe Tube |
| Version Model Number | RE367 |
| Catalog Number | RE367-40 |
| Company DUNS | 244780581 |
| Company Name | Etymonic Design Incorporated |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com | |
| Phone | 519-268-3313 |
| keith.harasyn@audioscan.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B161RE3670 [Primary] |
| HIBCC | B161RE3671 [Package] Package: [40 Units] In Commercial Distribution |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2020-01-15 |
| B161RE3670 - Audioscan Probe Tube | 2020-01-23Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker. |
| B161RE3670 - Audioscan Probe Tube | 2020-01-23 Molded probe tube, consisting of a thin silicone tube, molded collar, and adjustable ring marker. |
| B161VA3003 - Verifit Skull Simulator | 2019-05-10 An optional accessory to the Audioscan Verifit VF-2 or Verifit VF-1 hearing aid analyzer or hearing instrument test (HIT) system |
| B161AXIOM3 - Audioscan | 2018-03-29 |
| B161RM500SL3 - Audioscan | 2018-03-29 The RM500SL is a portable hearing aid analyzer intended to be used by hearing care professionals such as audiologists and hearin |
| B161VERIFITVF20 - Audioscan | 2018-03-29 |