Primary Device ID | B3673240 |
NIH Device Record Key | 618ba450-d512-4102-a0db-17945e4e3766 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UE BioSleeve |
Version Model Number | 4 |
Catalog Number | 32 |
Company DUNS | 033139835 |
Company Name | AXIOBIONICS |
Device Count | 1 |
DM Exempt | false |
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 | false |
Serial Number | true |
Manufacturing Date | false |
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 | B3673240 [Primary] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-24 |
B3673600 | Cutaneous Electrode Garment |
B367360 | Cutaneous Electrode Garment |
B3673500 | Cutaneous Electrode Garment |
B3673440 | Cutaneous Electrode Garment |
B3673340 | Cutaneous Electrode Garment |
B3673240 | Cutaneous Electrode Garment |
B3673140 | Cutaneous Electrode Garment |
B3673010 | Cutaneous Electrode Garment |
B3673350 | Cutaneous Electrode Garment Released as revision 5 on 2017-11-28 |