FDA UDI
In Commercial Distribution
🇺🇸 United States
Vitalcontrol
DI: 00853879007164
·
Model: SEM44 Replacement Electrodes Set (Art.-No.: 666.70)
·
BEURER NORTH AMERICA, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
4
Basic Information
- Brand Name
- Vitalcontrol
- Primary DI
- 00853879007164
- Version / Model
- SEM44 Replacement Electrodes Set (Art.-No.: 666.70)
- Company Name
- BEURER NORTH AMERICA, L.P.
- Labeler DUNS
- 078497467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-05-29
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 08e082a2-4db6-4e21-b270-de1173f1051c
Device Description
Replacement Electrodes Set for use with SEM44 Vitalcontrol TENS / EMS device (Art.-No.: 666.64)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 20853879007168 | GS1 | Case Pack | 10 | In Commercial Distribution | |
| Package | 10853879007161 | GS1 | Inner Pack | 50 | In Commercial Distribution | |
| Primary | 00853879007164 | GS1 | ||||
| Unit of Use | 30853879007165 | GS1 |
Customer Contacts
- Phone
- 1-800-536-0366
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 45 | Millimeter | |
| Length | 45 | Millimeter |