Primary Device ID | B271CUPA0 |
NIH Device Record Key | 5c06552d-c21f-42c0-ad51-3838674100f0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Arthritis Controller Unit |
Version Model Number | CU+A |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B271CUPA0 [Primary] |
ILY | Lamp, Infrared, Therapeutic Heating |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-09-26 |
Device Publish Date | 2023-09-18 |
B271MCUI0 - MiniPort Main Controller Unit | 2023-10-10 |
B271ART1800 - ART180 | 2023-09-26 |
B271CUPA0 - Arthritis Controller Unit | 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 |