| Primary Device ID | 10816843021099 |
| NIH Device Record Key | 24ac2b2b-941e-4244-b9c8-19aaf9a20b0d |
| Commercial Distribution Discontinuation | 2019-05-20 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NoiseFree™ |
| Version Model Number | S017815 |
| 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 | 10816843021099 [Primary] |
| GS1 | 10816843021105 [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 |