| Primary Device ID | 00745129331603 |
| NIH Device Record Key | bfacd70d-f354-49ab-8896-599bb4791d51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cflex Reduce Full Leg SM SM SM Tall Left Black |
| Version Model Number | 240111-THT-L |
| Catalog Number | 240111-THT-L |
| 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 |
| 00745129331603 - Cflex Reduce Full Leg SM SM SM Tall Left Black | 2025-07-24Inelastic 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. |
| 00745129331603 - Cflex Reduce Full Leg SM SM SM Tall Left Black | 2025-07-24 Inelastic garment (or accessory) made of nylon and polyester which functions to increase the working pressure applied to the aff |
| 07611711872768 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872775 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872782 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872799 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07611711872805 - Textile Donning Gloves | 2025-07-24 A device made of natural latex intended to assist patients and caregivers in donning and removing compression stockings and garm |
| 07613378196225 - 862C-CUSTOM ECF2 AD SoftTop UNI °° Black | 2025-07-21 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |
| 07613378196232 - 862C-CUSTOM ECF2 AD SensinovaUnisex UNI °° Black | 2025-07-21 A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb u |