| Primary Device ID | 00745129315962 |
| NIH Device Record Key | 992b8272-8392-4974-8b54-7f1c57d15998 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cflex Contain Full Leg MD MD MD Reg Right Black |
| Version Model Number | 340222-THR-R |
| Catalog Number | 340222-THR-R |
| Company DUNS | 189738719 |
| Company Name | SIGVARIS INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 00745129315962 - Cflex Contain Full Leg MD MD MD Reg Right Black | 2025-02-20Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the affected limb by providing consistent, firm pressure. Can be used throughout the phases of decongestive therapy to reduce swelling and shape the limb. Available with or without a prescription. Its important to note that specific therapy or approaches used for lymphedema management should be tailored by the healthcare provider. This is a reusable, washable device. |
| 00745129315962 - Cflex Contain Full Leg MD MD MD Reg Right Black | 2025-02-20 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff |
| 00745129317522 - 143C MicroFiber Shades 15-20mmHg W A BlueButterfly | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 00745129317539 - 143C MicroFiber Shades 15-20mmHg W B BlueButterfly | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 00745129317546 - 143C MicroFiber Shades 15-20mmHg W C BlueButterfly | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 00745129317553 - 183C MicroFiber Shades 15-20mmHg M A BlueButterfly | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 00745129317560 - 183C MicroFiber Shades 15-20mmHg M B BlueButterfly | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 00745129317577 - 183C MicroFiber Shades 15-20mmHg M C Blue Butterflies | 2025-02-20 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378105326 - 579 Melany Donning & Doffing Large | 2025-02-04 A device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose). |