| Primary Device ID | 00894912002425 |
| NIH Device Record Key | 95b9ed62-99ed-4658-a3b8-fff52ccb2688 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T10M5S8C |
| Version Model Number | T10M5S8C |
| Catalog Number | T10M5S8C |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00894912002425 [Primary] |
| JOP | Transducer, Ultrasonic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-11-03 |
| Device Publish Date | 2016-03-10 |
| 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. |
| 00894912002340 - BT5M05S8C | 2023-11-03 5 MHz curly cable clinic CW Doppler probe. |