PURE ENRICHMENT
GUDID B311PEPADBFLY1
LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
Transcutaneous electrical stimulation electrode| Primary Device ID | B311PEPADBFLY1 |
| NIH Device Record Key | 042ceed0-5bf6-4206-b932-1ecb0644fc34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PURE ENRICHMENT |
| Version Model Number | PEPADBFLY |
| 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 | B311PEPADBFLY0 [Primary] |
| HIBCC | B311PEPADBFLY1 [Package] Contains: B311PEPADBFLY0 Package: MASTER CARTON [350 Units] In Commercial Distribution |
| HIBCC | B311PEPADBFLY2 [Package] Contains: B311PEPADBFLY0 Package: MASTER CARTON [250 Units] In Commercial Distribution |
| HIBCC | B311PEPADBFLY3 [Package] Contains: B311PEPADBFLY0 Package: INDIVIDUAL PACKAGE [2 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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