| Primary Device ID | 05701780221641 |
| NIH Device Record Key | 9b478032-dfbd-4c01-a9c9-194770e88043 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeediCath Flex Set |
| Version Model Number | 28932 |
| Catalog Number | 28932 |
| 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 | 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Catheter Working Length | 33 Centimeter |
| Outer Diameter | 4 Millimeter |
| Outer Diameter | 0.16 Inch |
| Catheter Gauge | 12 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05701780221535 [Package] Contains: 05708932748476 Package: Retail Box [30 Units] In Commercial Distribution |
| GS1 | 05701780221641 [Package] Contains: 05701780221535 Package: Shipper Box [3 Units] In Commercial Distribution |
| GS1 | 05708932748476 [Primary] |
| EZD | CATHETER, STRAIGHT |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-17 |
| Device Publish Date | 2022-10-09 |
| 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 |