PURE ENRICHMENT
GUDID B311PEPROPAD0
PACK OF ELECTRODES
BEAR DOWN CONSULTING
Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use| Primary Device ID | B311PEPROPAD0 |
| NIH Device Record Key | 61b8460a-2b49-4a32-9185-3c57cc4d8a2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PURE ENRICHMENT |
| Version Model Number | PEPROPAD |
| Company DUNS | 040869867 |
| Company Name | BEAR DOWN CONSULTING |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B311PEPROPAD0 [Primary] |
| HIBCC | B311PEPROPAD1 [Package] Package: INDIVIDUAL PACKAGE [5 Units] In Commercial Distribution |
| HIBCC | B311PEPROPAD2 [Package] Package: MASTER CARTON [100 Units] In Commercial Distribution |
| HIBCC | B311PEPROPAD3 [Package] Package: INDIVIDUAL PACKAGE [10 Units] In Commercial Distribution |
| HIBCC | B311PEPROPAD4 [Package] Package: MASTER CARTON [50 Units] In Commercial Distribution |
| HIBCC | B311PEPROPAD5 [Package] Package: MASTER CARTON [400 Units] In Commercial Distribution |
| HIBCC | B311PEPROPAD6 [Package] Package: MASTER CARTON [250 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K082065
FDA Product Code
| GXY | Electrode, Cutaneous |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-19 |
On-Brand Devices [PURE ENRICHMENT]
| 00853975005651 | neck heating pad |
| 00853975005644 | heating pad |
| 00853975005613 | neck heating pad |
| 00853975005606 | heating pad |
| 00853975005583 | Heating and cooling pad |
| B311PETENSPAD5 | ELECTRODE PADS |
| B311PEPULSEPRO1 | TENS UNIT |
| B311PEPULSEDUO0 | TENS & EMS UNIT |
| B311PEPULSE1 | TENS UNIT |
| B311PEPROPAD0 | PACK OF ELECTRODES |
| B311PEPROBELT0 | THERAPY BELT FOR BACK. |
| B311PEPADBFLY1 | LARGE ELECTRODE PAD |
| B311PEFETDPL1 | Fetal Doppler. Used to hear heart rate sounds. |
| B311PEBRPUMP1 | Dual electric breast pump. |
| 00817387022545 | PELUXWAV-S |
| 00817387022538 | PEPNTLUX-A |
| 00817387022521 | PEDESHBN |
| 00817387022514 | PEHPALM-A |
| 00817387022507 | PEHPGTREL |
| 00817387022491 | PEHPNVGR |
| B311PEPEAK1 | Massager, therapeutic, electric |
| 00817387022477 | PEWTPLRG-L |
| 00817387022460 | PEWTPSML-L |
| 00817387020800 | heating pad |
| 00817387020732 | Heating Pad for Back and Neck |
| 00817387020725 | heating pad |
| 00817387020718 | heating pad |
| 00817387020688 | heating and cooling lumbar pad |
| 00817387020596 | heating pad |
| 00817387020206 | Heating pad |
| 00817387024075 | Weighted Heating Pad |
| 00817387024273 | Weighted Neck Heating Pad |
| 00817387025997 | PEHT24RT-G |
| 00817387025010 | PEHPWD2-G |
| 00817387026147 | PECLPBK-MG |
| 00817387026130 | PEWDVAL-AT |
| 00817387025829 | PEHPVAL-RB |
| 00817387025812 | PEHPAD24-ZG |
| 00817387026154 | PECLPNE-MG |
| 00817387026512 | PECERDIA |
| 00817387026505 | PELAULVS |
| 00817387026574 | PEWDVAL-G |
| 00817387022637 | PEHTWGHT-G |
| 00817387026888 | PEWTVAL-MT |
| 00817387022187 | PEHPWIDE-SG |
| 00817387022170 | PEHPBACK-SG |
| 00817387027465 | PEHPBACK-CG |
| B311PEPULSERT0 | PEPULSE-RT |
| B311PETNEMPD51 | Wired TENS+EMS+HEAT Replacement Gel Pads |
| B311PETNEMPD21 | Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets |
Trademark Results [PURE ENRICHMENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURE ENRICHMENT 97631610 not registered Live/Pending |
Bear Down Brands, LLC 2022-10-13 |
 PURE ENRICHMENT 88244295 not registered Live/Pending |
Bear Down Brands, LLC 2018-12-28 |
 PURE ENRICHMENT 85703766 4279999 Live/Registered |
BEAR DOWN BRANDS, LLC 2012-08-14 |
 PURE ENRICHMENT 85653412 4279854 Live/Registered |
BEAR DOWN BRANDS, LLC 2012-06-15 |
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