| Primary Device ID | 10817122020444 |
| NIH Device Record Key | f6b14a9a-38f3-46a1-a8fb-a5aa7920f37f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GEM IntraOp Doppler, Hand-Held Dopplers |
| Version Model Number | 128770 |
| Catalog Number | 128770 |
| Company DUNS | 161989343 |
| Company Name | VASCULAR TECHNOLOGY, INCORPORATED |
| Device Count | 4 |
| 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 | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| 00817122020560 - VTI 8MHz TRANS-Q-TANEOUS INTRA OPERATIVE DOPPLER SYSTEM | 2024-02-02 Part Number: 108850, Gen 0.5, VTI 8MHz TRANS-Q-TANEOUS INTRA OPERATIVE DOPPLER SYSTEM |
| 00817122020577 - Footswitch, Mute, for use with VTI TQI Doppler Gen 0.5 | 2024-02-02 Part Number: 201450, Footswitch, Mute, Doppler |
| 00817122020584 - Pole Mount for use with VTI TQI Doppler, Gen 0.5 | 2024-02-02 Part Number: 201455, Pole Mount |
| 00817122020515 - Latching Foot Switch for Use with 106400 | 2023-10-18 Part Number 201202, Foot Switch Latching Suction, for ROSI |
| 00817122020522 - ROSI xT Tubing set for use with Exchangeable tips, Pouch | 2023-10-18 Part Number 106450, ROSI tubing set, Exchangeable tip. Each |
| 10817122020048 - VTI 20 MHZ Disposable Doppler Probe, Curved Tip, Box | 2021-04-07 Part Number 102802, VTI 20 MHZ Disposable Doppler Probe Curved, Sterile, Box |
| 10817122020154 - VTI 20 MHZ Disposable Doppler Probe, Straight, Box | 2021-04-07 Part Number 108200, VTI 20 MHZ Disposable Doppler Probe, Straight, Box |
| 10817122020161 - VTI 8 MHZ Disposable Doppler Probe, Straight, Box | 2021-04-07 Part Number 108260, VTI 8 MHZ Disposable Doppler Probe, Straight, Box |