| Primary Device ID | 00894912002623 | 
| NIH Device Record Key | 17934d89-fac7-49b2-9bd8-2b5259cedef6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | VDP-8 | 
| Version Model Number | VDP-8 | 
| Catalog Number | VDP-8 | 
| Company DUNS | 069261402 | 
| Company Name | KOVEN TECHNOLOGY, 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | |
| Phone | 314-542-2101 | 
| info@koven.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00894912002623 [Primary] | 
| JAF | Monitor, Ultrasonic, Nonfetal | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2021-04-07 | 
| Device Publish Date | 2016-07-05 | 
| 00894912002067 - PAUS | 2025-01-09 Modality Worklist Software | 
| 00894912002043 - BiDop 3 | 2023-11-03 Bidirectional Doppler with waveform display. | 
| 00894912002197 - PG-21 | 2023-11-03 PPG probe module. | 
| 00894912002203 - PGV-20 | 2023-11-03 PPG and Pulse Volume combo module for Smartdops. | 
| 00894912002296 - BF8M15S8A | 2023-11-03 8 MHz flat clinic CW Doppler probe. | 
| 00894912002302 - BT10M5S8A | 2023-11-03 10 MHz straight cable clinic CW Doppler probe. | 
| 00894912002319 - BT10M5S8C | 2023-11-03 10 MHz curly cable clinic CW Doppler probe. | 
| 00894912002333 - BT5M05S8A | 2023-11-03 5 MHz straight cable clinic CW Doppler probe. |