| Primary Device ID | B271LSB48900 |
| NIH Device Record Key | 55b51dde-85d4-4693-b917-bb66ad3e4010 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUOFLEX+ 180 Treatment Head |
| Version Model Number | LS-B 4890 |
| Company DUNS | 255079485 |
| Company Name | Meditech International 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 | false |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B271LSB48900 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-02-01 |
| B271MCUI0 - MiniPort Main Controller Unit | 2023-10-10 |
| B271ART1800 - ART180 | 2023-09-26 |
| B271CUPA0 - Arthritis Controller Unit | 2023-09-26 |
| B271CU0 - CU Controller | 2018-07-06 |
| B271CUP0 - CU+ Controller | 2018-07-06 |
| B271DUO1800 - DUO+ 180 Treatment Head | 2018-07-06 |
| B271DUO2400 - DUO+ 240 Treatment Head | 2018-07-06 |
| B271LDI2000 - LD-I 200 Treatment Head | 2018-07-06 |