Primary Device ID | 10816843021136 |
NIH Device Record Key | 4b24a083-73b2-4607-93ef-d634c4e8d629 |
Commercial Distribution Discontinuation | 2019-05-20 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | NoiseFree™ |
Version Model Number | S018315 |
Company DUNS | 068156330 |
Company Name | ROCHESTER ELECTRO-MEDICAL, INC. |
Device Count | 5 |
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 | true |
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 | true |
OTC Over-The-Counter | false |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com | |
Phone | 18003285544 |
info@rochestermed.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10816843021136 [Primary] |
GS1 | 10816843021143 [Unit of Use] |
GXY | Electrode, Cutaneous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2022-11-28 |
Device Publish Date | 2016-09-24 |
10816843021136 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 4 FT. (1.2 M), SINGLE, SILICO |
10816843021112 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 8 FT. (2.5 M), SINGLE, SILICONE WIRE |
10816843021099 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE |
10816843021075 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 8 FT. (2.5 M), SINGLE, SILICO |
10816843021051 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: SILVER/CHLORIDE DISC, 6 FT. (1.8 M), SINGLE, SILICO |
10816843021037 | REUSABLE NOISEFREE BIO-POTENTIAL ELECTRODES: GOLD DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
NOISEFREE 75140384 2101196 Dead/Cancelled |
Compatibility Products Corporation 1996-07-26 |