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 |