BodyMed NPP619
GUDID 00815802014939
BOYDMED 2" X 3.5" RECTANGULAR WHITE FOAM CARBON ELECTRODE, 4/PK
BOXOUT, LLC
Transcutaneous electrical stimulation electrode| Primary Device ID | 00815802014939 |
| NIH Device Record Key | e9a88847-f04f-40c8-8991-1b680282d9d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BodyMed |
| Version Model Number | NPP619 |
| Catalog Number | NPP619 |
| Company DUNS | 066689993 |
| Company Name | BOXOUT, LLC |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815802014939 [Primary] |
| GS1 | 10815802014936 [Package] Package: Inner box [45 Units] In Commercial Distribution |
| GS1 | 20815802014933 [Package] Contains: 10815802014936 Package: Master carton [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092546
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 | 4 |
| Public Version Date | 2020-02-27 |
| Device Publish Date | 2016-09-05 |
On-Brand Devices [BodyMed]
| 00815991022081 | BODYMED IONTOPHORESIS, ELECTRODES BUTTERFLY 3.75" X 3.75", 12/BOX |
| 00815991022074 | BODYMED IONTOPHORESIS, ELECTRODES LARGE, 3.5" X 3.5", 12/BOX |
| 00815991022067 | BODYMED IONTOPHORESIS, ELECTRODES MEDIUM 3.25" X 3.25", 12/BOX |
| 00815991022050 | BODYMED IONTOPHORESIS, ELECTRODE SMALL 2.75" X 2.75", 12/BOX |
| 20815991021699 | CARBON ELECTRODE, 3" BY 4.75" RECTANGULAR. 1PC/BAG |
| 20815991021682 | CARBON ELECTRODE, 3.75" ROUND. 1PC/BAG |
| 20815991021675 | CARBON ELECTRODE, 3.3" ROUND. 1PC/BAG |
| 20815991021668 | CARBON ELECTRODE, 2.5" ROUND. 1PC/BAG |
| 20815991020586 | BODYMED 3" X 5" RECTANGULAR CLOTH BACK CARBON ELECTRODE, LATEX FREE, 2/PACK, SOLD BY 10 PACKS |
| 00815991020575 | BODYMED SELF-ADHERING ELECTRODES, FABRIC BACK, 2" X 4" OVAL, SOLD BY 10 PACKS |
| 00815991020551 | BODYMED SELF ADHESIVE ELECTRODE 2X2, FABRIC BACKING, 520/CASE |
| 00815991020377 | Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case, an adapter and |
| 00815802019910 | BODYMED OVER THE COUNTER SELF-ADHERING ELECTRODE, FABRIC BACK, 2" ROUND, 4/PACKAGE |
| 00815802019903 | BODYMED OVER THE COUNTER SELF-ADHERING ELECTRODE, FABRIC BACK, 2" X 2" SQUARE, 4/PACKAGE |
| 00815802018821 | BODYMED DIGITAL OVER THE COUNTER TENS UNIT |
| 00815802018807 | BODYMED DIGITAL TENS/EMS/IF COMBO, TWO CHANNEL |
| 00815802018791 | BODYMED ECONOMY TENS, ANALOG TWO CHANNEL 3 MODE TENS WITH TIMER |
| 00815802018722 | BODYMED LED MOIST AND DRY HEATING PAD, 12" X 15" |
| 20815802018719 | BodyMed Digital Heating Pad 14"x27", black cover |
| 00815802018524 | 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE, PRIVATE LABEL FOR GOLDEN STATE LOGO, 4/PK |
| 00815802017459 | BODYMED 2" X 4" OVAL WHITE FOAM CARBON ELECTRODE, 4/PK |
| 00815802017442 | BODYMED 1.5" X 2.5" OVAL WHITE FABRIC CARBON ELECTRODE, 4/PK |
| 00815802017435 | BODYMED 1.5" X 2.5" OVAL WHITE FOAM CARBON ELECTRODE, 4/PK |
| 00815802015578 | 2" X 2" SQUARE WHITE FABRIC CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015561 | 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015554 | 2" X 3.5" RECTANGULAR WHITE FOAM CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015547 | 2" ROUND WHITE FABRIC CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015530 | 2" ROUND WHITE FOAM CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015523 | 2" X 2" SQUARE WHITE FOAM CARBON ELECTRODE FOR CUSTOM STICKER, 4/PK |
| 00815802015066 | BODYMED 3" X 5" BLUE GEL CARBON ELECTRODE, RECTANGULAR, WHITE, 2/PK |
| 00815802015059 | BODYMED 2" X 3.5" BLUE GEL CARBON ELECTRODE, RECTANGULAR, WHITE FABRIC, 4/PK |
| 00815802015042 | BODYMED 2" BLUE GEL CARBON ELECTRODE, ROUND, WHITE FABRIC, 4/PK |
| 00815802015035 | BODYMED 2" X 2" BLUE GEL CARBON ELECTRODE, SQUARE, WHITE FABRIC , 4/PK |
| 00815802014946 | BODYMED REUSABLE 2" X 3.5" RECTANGULAR WHITE FABRIC CARBON ELECTRODE, 4/PK |
| 00815802014939 | BOYDMED 2" X 3.5" RECTANGULAR WHITE FOAM CARBON ELECTRODE, 4/PK |
| 00815802014922 | BODYMED REUSABLE 2" ROUND WHITE FABRIC CARBON ELECTRODE, 4/PK |
| 00815802014915 | BODYMED 2" ROUND WHITE FOAM CARBON ELECTRODE, 4/PK |
| 00815802014908 | BODYMED 2" X 2" SQUARE WHITE FOAM CARBON ELECTRODE, 4/PK |
| 00815802014533 | BODYMED DIGITAL 4 CHANNEL DIGITAL TENS/EMS UNIT |
| 00815802014526 | BODYMED DIGITAL EMS DUAL CHANNEL UNIT INCLUDES 2 LEAD WIRES, 1 PACK OF 4-1 3/4" ROUND CLOTH ELE |
| 00815802014519 | BODYMED ANALOG DUAL CHANNEL TENS/EMS COMBINATION UNIT WITH TIMER INCLUDES INCLUDES 2 LEAD WIRES, |
| 00815802014502 | BODYMED 2 CHANNEL DIGITAL TENS UNIT |
| 00815802014496 | BODYMED ANALOG TENS |
| 00815802014465 | BODYMED REPLACEMENT BLOOD PRESSURE UNIVERSAL CUFF, 22CM-52CM |
| 20815802014452 | BODYMED UPPER ARM BLOOD PRESSURE MONITOR WITH UNIVERSAL CUFF, DIGITAL, 22CM-52CM |
| 00815802014427 | 2" X 2" SQUARE WHITE FABRIC ELECTRODE, TENSPEDE LOGO |
| 00815802014410 | 2" X 2" SQUARE WHITE FABRIC ELECTRODE, GOLDEN STATE LOGO |
| 20815802010874 | BODYMED ANALOG DUAL CHANNEL INTERFERENTIAL UNIT |
| 00815802010375 | BODYMED SELF-ADHERING ELECTRODES, FABRIC BACK, REUSABLE, 2" X 2" SQUARE, 4/PK |
| 00815802010368 | BODYMED2" X 3 1/2" RECTANGULAR SILVER CARBON ELECTRODE, CLOTH BACK, REUSABLE, 4/PK |
Trademark Results [BodyMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BODYMED 77951357 3967413 Live/Registered |
WBC GROUP, LLC 2010-03-05 |
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