FDA UDI
In Commercial Distribution
🇺🇸 United States
BodyMed
DI: 00815802010252
·
Model: NPP605
·
BOXOUT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- BodyMed
- Primary DI
- 00815802010252
- Version / Model
- NPP605
- Catalog Number
- NPP605
- Company Name
- BOXOUT, LLC
- Labeler DUNS
- 066689993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-05
- Public Version
- 7
- Public Version Date
- 2023-08-14
- Public Version Status
- Update
- Public Device Record Key
- f57d58ef-b146-42fe-9883-eb819e22bd87
Device Description
BODYMED 1 1/4" ROUND CLOTH BACK CARBON ELECTRODE, WHITE, LATEX FREE, 4/PACK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXY | Electrode, Cutaneous | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815802010252 | GS1 | ||||
| Package | 10815802010259 | GS1 | Inner box | 50 | In Commercial Distribution | |
| Package | 20815802010256 | GS1 | Master carton | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 866-528-2152
- [email protected]