Tens 7000
GUDID 00092237622162
Tens 7000 OTC Electrodes, White Cloth, Mixed 32/pk Includes (16) 2" x 2" square electrodes and (16) 2" x 4" rectangle electrodes
COMPASS HEALTH BRANDS CORP.
Transcutaneous electrical stimulation electrode| Primary Device ID | 00092237622162 |
| NIH Device Record Key | b85166df-2314-4f84-84b1-cc03754bd195 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tens 7000 |
| Version Model Number | DT7202-ELEC204032 |
| Company DUNS | 827221698 |
| Company Name | COMPASS HEALTH BRANDS CORP. |
| Device Count | 32 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00092237622162 [Primary] |
| GS1 | 01092237622161 [Unit of Use] |
| GS1 | 30092237622163 [Package] Package: Inner Carton [7 Units] In Commercial Distribution |
| GS1 | 80092237622168 [Package] Contains: 30092237622163 Package: Master Carton [8 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K171721
FDA Product Code
| GXY | Electrode, Cutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-03 |
| Device Publish Date | 2020-01-24 |
On-Brand Devices [Tens 7000]
| 00092237622162 | Tens 7000 OTC Electrodes, White Cloth, Mixed 32/pk Includes (16) 2" x 2" square electrodes and |
| 00092237624555 | TENS 7000 Rechargeable 4 Channel DDX |
| 00092237624548 | TENS 7000 Rechargeable + EMS DDX |
| 00092237624531 | TENS 7000 Rechargeable DDX |
| 30092237626642 | TENS 7000 Menstrual TENS |
| 80023601680378 | TENS 7000 w 16 pk |
| 80023601680064 | TENS 7000 w 48 pk |
| 30092237626659 | TENS 7000 Migraine TENS |
Trademark Results [Tens 7000]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TENS 7000 85372176 4134482 Live/Registered |
COMPASS HEALTH BRANDS CORP. 2011-07-15 |
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