| Primary Device ID | 05708932558952 |
| NIH Device Record Key | a99938ad-7e15-459b-af97-6e5fd9caab4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpeediCath Compact |
| Version Model Number | 28814 |
| Catalog Number | 28814 |
| 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 |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
| Device Size Text, specify | 0 |
| Catheter Gauge | 14 French |
| Outer Diameter | 4.7 Millimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Catheter Gauge | 14 French |
| Device Size Text, specify | 0 |
| Catheter Working Length | 3.5 Inch |
| Catheter Working Length | 9 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if sterile barrier is damaged |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932020633 [Primary] |
| GS1 | 05708932024662 [Package] Contains: 05708932020633 Package: Sample pack [5 Units] In Commercial Distribution |
| GS1 | 05708932558945 [Package] Contains: 05708932020633 Package: Retail box [30 Units] In Commercial Distribution |
| GS1 | 05708932558952 [Package] Contains: 05708932558945 Package: Shipper box [10 Units] In Commercial Distribution |
| EZD | Catheter, straight |
| GBM | CATHETER, URETHRAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-02 |
| 05708932534475 | SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea |
| 05708932534482 | SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea |
| 05708932653053 | SpeediCath Compact with SpeediBag. Urinary catheter for intermittent catheterization. Ready to u |
| 05708932640572 | SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe |
| 05708932624688 | SpeediCath Compact Male Kit. Compact with SpeediBag. Urinary catheter for intermittent catheteri |
| 05708932618755 | SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate |
| 05708932618724 | SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate |
| 05708932618700 | SpeediCath Compact Eve. Sterile urinary catheter for intermittent use. Female ready-to-use coate |
| 05708932579018 | SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe |
| 05708932543965 | SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea |
| 05708932543941 | SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Rea |
| 05708932024754 | SpeediCath Compact with SpeediBag sample pack. Urinary catheter for intermittent catheterization |
| 05708932024709 | SpeediCath Compact Male Kit sample pack. Compact with SpeediBag. Urinary catheter for intermitte |
| 05708932558952 | SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated |
| 05708932558921 | SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated |
| 05708932558907 | SpeediCath Compact Plus. Urinary catheter for intermittent catheterization. Ready to use coated |
| 05708932640527 | SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe |
| 05708932640534 | SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe |
| 05708932024693 | SpeediCath Compact. Urinary catheter for intermittent catheterization. Ready to use coated cathe |
| 05708932020558 | SpeediCath Compact female CH10 |