| Primary Device ID | 00856492005661 |
| NIH Device Record Key | 8bd4e674-9ad1-4e10-b728-41da545dc80c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spex LP |
| Version Model Number | SLP18090US |
| Company DUNS | 962545294 |
| Company Name | REFLOW MEDICAL, 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 |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Working Length | 90 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856492005661 [Primary] |
| GS1 | 10856492005668 [Package] Package: [5 Units] In Commercial Distribution |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-18 |
| Device Publish Date | 2020-05-08 |
| 00856492005685 | speX LP Shapeable Support Catheter, 18 X 150cm, US |
| 00856492005678 | speX LP Shapeable Support Catheter, 18 X 135cm, US |
| 00856492005661 | speX LP Shapeable Support Catheter, 18 X 90cm, US |
| 00856492005654 | speX LP Shapeable Support Catheter, 14 X 150cm, US |
| 00856492005647 | speX LP Shapeable Support Catheter, 14 X 135cm, US |
| 00856492005630 | speX LP Shapeable Support Catheter, 14 X 90cm, US |
| 10850025525036 | speX LP Shapeable Support Catheter, 35 X 150cm, US |
| 10850025525029 | speX LP Shapeable Support Catheter, 35 X 135cm, US |
| 00850025525015 | speX LP Shapeable Support Catheter, 35 X 90cm, US |