| Primary Device ID | 00850025525060 |
| NIH Device Record Key | 553a3fe2-a625-4ada-a3df-207686b81548 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEX35 |
| Version Model Number | SPN35050US |
| 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 | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Catheter Working Length | 50 Centimeter |
| Guidewire Diameter | 0.035 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025525060 [Primary] |
| GS1 | 10850025525067 [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 | 2021-10-01 |
| Device Publish Date | 2021-09-23 |
| 00856492005135 | Spex Shapeable Support Catheter, 35X50cm |
| 00856492005128 | Spex Shapeable Support Catheter, 35X90cm |
| 00856492005111 | Spex Shapeable Support Catheter, 35X135cm |
| 00856492005104 | Spex Shapeable Support Catheter, 35X150cm |
| 00850025525091 | Spex Shapeable Support Catheter, 35 X 150cm, US |
| 00850025525084 | Spex Shapeable Support Catheter, 35 X 135cm, US |
| 00850025525077 | Spex Shapeable Support Catheter, 35 X 90cm, US |
| 00850025525060 | Spex Shapeable Support Catheter, 35 X 50cm, US |