Primary Device ID | B2075002960 |
NIH Device Record Key | fa0bd12a-53f7-4c03-aab1-e292de25ab3b |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | NEXT |
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 | true |
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 | B2075002960 [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 | 2018-03-29AUDIOMETER |
B2075002960 - NA | 2018-03-29 AUDIOMETER |
B2075003030 - NA | 2018-03-29 AUDIOMETER |
B2075003070 - NA | 2018-03-29 AUDIOMETER |
B2075003220 - NA | 2018-03-29 AUDIOMETER |
B2075004420 - Benson Medical Instruments Co. | 2018-03-29 Fit Test Audiometer |