| Primary Device ID | 00856492005135 |
| NIH Device Record Key | 951adbf0-8d58-44b0-88dd-5620002a0320 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEX35 |
| Version Model Number | SPX35050US |
| Catalog Number | SPX35050US |
| 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 |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Length | 50 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856492005135 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-10-30 |
| Device Publish Date | 2016-09-16 |
| 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 |