| Primary Device ID | 00850078826039 |
| NIH Device Record Key | 493d0a5c-5958-43ae-8bf4-1ee7bda97f1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioTAB LLC |
| Version Model Number | PNFL-SL-01 |
| Company DUNS | 557464257 |
| Company Name | Biotab LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078826039 [Primary] |
| JOW | Sleeve, Limb, Compressible |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 00850078826183 | Unilateral Y-Connector |
| 00850078826176 | Bilateral Y-Connector |
| 00850078826169 | TALL CORE GARMENT – LARGE |
| 00850078826152 | TALL CORE GARMENT – MEDIUM |
| 00850078826145 | TALL CORE GARMENT – SMALL |
| 00850078826138 | STANDARD CORE GARMENT – LARGE |
| 00850078826121 | STANDARD CORE GARMENT – MEDIUM |
| 00850078826114 | STANDARD CORE GARMENT – SMALL |
| 00850078826107 | TALL FULL LEG GARMENT – 2X-LARGE |
| 00850078826091 | TALL FULL LEG GARMENT – X-LARGE |
| 00850078826084 | TALL FULL LEG GARMENT – LARGE |
| 00850078826077 | TALL FULL LEG GARMENT – MEDIUM |
| 00850078826060 | TALL FULL LEG GARMENT – SMALL |
| 00850078826053 | STANDARD FULL LEG GARMENT – 2X-LARGE |
| 00850078826046 | STANDARD FULL LEG GARMENT – X-LARGE |
| 00850078826039 | STANDARD FULL LEG GARMENT - LARGE |
| 00850078826022 | STANDARD FULL LEG GARMENT - MEDIUM |
| 00850078826015 | STANDARD FULL LEG GARMENT - SMALL |
| 00199284566231 | PnueAira Lymphedema Pump |