| Primary Device ID | 00856492005364 |
| NIH Device Record Key | 9bf58c50-982d-48e2-9a97-747353323010 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEX14 |
| Version Model Number | SPX14135US |
| Catalog Number | SPX14135US |
| 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 | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Length | 135 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856492005364 [Primary] |
| DQY | Catheter, Percutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-01-23 |
| Device Publish Date | 2018-08-06 |
| 00856492005371 | Spex Shapeable Support Catheter, 14X150cm |
| 00856492005364 | Spex Shapeable Support Catheter, 14X135cm |
| 00856492005357 | Spex Shapeable Support Catheter, 14X90cm |