| Primary Device ID | B139WV00090 |
| NIH Device Record Key | 5cc0aa47-b245-4fe5-bafd-c61b95761d3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JETi Pump Set |
| Version Model Number | WV0009 |
| Catalog Number | WV0009 |
| Company DUNS | 034774488 |
| Company Name | WALK VASCULAR L.L.C. |
| 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 |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 607 Millimeter of Mercury and 810 Millimeter of Mercury |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 13 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B139WV00090 [Primary] |
| DXE | Catheter, Embolectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
[B139WV00090]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-24 |
| B139WV00100 | WV0010 |
| B139WV00090 | WV0009 |
| B139WVJSET11 | WV-JSET-1 |
| B139WVJSET1 | WV-JSET |