Primary Device ID | 06944413800168 |
NIH Device Record Key | 67a2f6c3-3f4f-43e7-aa9e-8ec7b3ab108b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ultrasonic Pocket Doppler |
Version Model Number | SONOTRAX Ⅱ |
Company DUNS | 529173163 |
Company Name | Edan Instruments, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06944413800168 [Primary] |
GS1 | 6944413802421 [Package] Package: [10 Units] In Commercial Distribution |
KNG | Monitor, Ultrasonic, Fetal |
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 | 2016-09-01 |
06944413808751 | SD1 |
06944413806795 | PD-1000 Plus |
06944413806788 | PD-1000 |
06944413806771 | PD-100 Pro |
06944413806764 | PD-100 Plus |
06944413806757 | PD-1000 Pro |
06944413806740 | PD-100B |
06944413806733 | PD-100A |
06944413802032 | SD3 Vascular |
06944413801813 | SD3 PRO |
06944413801806 | SD3 PLUS |
06944413801790 | SD3 LITE |
06944413801783 | SD3 |
06944413800564 | SONOTRAX Vascular |
06944413800175 | SONOTRAX Ⅱ Pro |
06944413800168 | SONOTRAX Ⅱ |
06944413800151 | SONOTRAX Pro |
06944413800144 | SONOTRAX Basic A |
06944413800137 | SONOTRAX Basic |
06944413800120 | SONOTRAX Lite |