| Primary Device ID | B2075003070 |
| NIH Device Record Key | 9ad35d05-ae88-4bf1-8298-c5afca01ae3b |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | CCA-100M |
| Catalog Number | NA |
| Company DUNS | 957930696 |
| Company Name | BENSON MEDICAL INSTRUMENTS COMPANY |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | true |
| Phone | 612-827-2222 |
| TECHSUPPORT@BENSONMEDICAL.COM | |
| Phone | 612-827-2222 |
| TECHSUPPORT@BENSONMEDICAL.COM |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B2075003070 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-16 |
| B207500326100 - NA | 2020-03-23 U-tube Mouthpieces |
| B207500434100 - NA | 2020-03-23 U-tube Mouthpieces |
| B2075003470 - NA | 2018-07-06 SPIROMETER |
| B2075002960 - NA | 2018-03-29 AUDIOMETER |
| B2075003030 - NA | 2018-03-29 AUDIOMETER |
| B2075003070 - NA | 2018-03-29AUDIOMETER |
| B2075003070 - NA | 2018-03-29 AUDIOMETER |
| B2075003220 - NA | 2018-03-29 AUDIOMETER |
| B2075004420 - Benson Medical Instruments Co. | 2018-03-29 Fit Test Audiometer |