| Primary Device ID | 10818323027232 |
| NIH Device Record Key | 3367a91c-6b0a-4a72-8270-cf51a2000fea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vive Sole |
| Version Model Number | INS1023ML |
| Company DUNS | 047025993 |
| Company Name | VIVE HEALTH LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818323027235 [Primary] |
| GS1 | 10818323027232 [Package] Contains: 00818323027235 Package: Case [100 Units] In Commercial Distribution |
| KNP | Orthosis, Corrective Shoe |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-26 |
| Device Publish Date | 2019-03-18 |
| 10810178880864 - BioTab | 2024-12-10 BT Lymphedema Pump (PCD) 8 Chamber (Small Wide) |
| 10810178880871 - BioTab | 2024-12-10 BT Lymphedema Pump (PCD) 8 Chamber (Large) |
| 10810178880888 - BioTab | 2024-12-10 BT Lymphedema Pump (PCD) 8 Chamber (Extra Wide) |
| 10810178881168 - BioTab | 2024-12-10 BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Small) |
| 10810178881175 - BioTab | 2024-12-10 BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Mediuml) |
| 10810178881182 - BioTab | 2024-12-10 BT Lymphedema Pump 8 Chamber Replacement Leg Sleeve (Medium Wide) |
| 10810041981971 - Vive | 2024-11-01 Crutch Pads (Plaid) |
| 10810041981988 - Vive | 2024-11-01 Crutch Pads (Paisley) |