| Primary Device ID | 05708932778268 |
| NIH Device Record Key | 0633afae-1d3d-4532-a7eb-b014b6c66808 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeediCath Flex Set |
| Version Model Number | 28941 |
| Catalog Number | 28941 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
| Catheter Working Length | 13 Inch |
| Catheter Gauge | 10 French |
| Catheter Working Length | 33 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 13 Inch |
| Catheter Gauge | 10 French |
| Catheter Working Length | 33 Centimeter |
| Device Size Text, specify | 0 |
| Catheter Working Length | 13 Inch |
| Catheter Gauge | 10 French |
| Catheter Working Length | 33 Centimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932778114 [Primary] |
| GS1 | 05708932778268 [Package] Contains: 05708932778114 Package: Shipper Box [50 Units] In Commercial Distribution |
| FCM | Tray, catheterization, sterile urethral, with or without catheter (kit) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-13 |
| Device Publish Date | 2026-02-05 |
| 05701780221559 | SpeediCath Flex Set CH16 |
| 05701780221658 | SpeediCath Flex Set CH14 |
| 05701780221641 | SpeediCath Flex Set CH12 |
| 05701780221627 | SpeediCath Flex Set CH10 |
| 05708932753081 | 28946 |
| 05708932755894 | 28944 |
| 05708932755870 | 28942 |
| 05708932755856 | 28941 |
| 05708932778282 | 28946 |
| 05708932778275 | 28942 |
| 05708932778268 | 28941 |