| Primary Device ID | 00184360000112 |
| NIH Device Record Key | 9a3b9d77-88fb-4509-9791-e8cdc25115a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FloWire Floppy Doppler Guide Wire ST |
| Version Model Number | 1400 |
| Company DUNS | 135179237 |
| Company Name | VOLCANO CORPORATION |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00184360000112 [Primary] |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-24 |
| 20845225012681 - SpinVision STERILE EQUIPEMENT COVER | 2021-10-26 |
| 20845225012698 - DIGITAL IVUS STERILE EQUIPEMENT COVER | 2021-10-26 |
| 10845225012707 - R-100 STERILE EQUIPEMENT COVER | 2021-10-26 |
| 00845225012915 - IntraSight Mobile | 2021-02-03 |
| 00845225012847 - FM-PIM | 2021-01-29 |
| 00845225012656 - CORE FM CART | 2020-06-02 |
| 00845225010874 - ComboMap Pressure and Flow System | 2020-01-01 |
| 00845225002565 - Pioneer Plus Catheter | 2019-03-21 |