FDA UDI
In Commercial Distribution
🇺🇸 United States
TENS Electrode Set
DI: 00754756740016
·
Model: S1000E
·
ESSENTIAL MEDICAL SUPPLY INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- TENS Electrode Set
- Primary DI
- 00754756740016
- Version / Model
- S1000E
- Company Name
- ESSENTIAL MEDICAL SUPPLY INC
- Labeler DUNS
- 189331325
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-11
- Public Version
- 3
- Public Version Date
- 2019-10-23
- Public Version Status
- Update
- Public Device Record Key
- 21df2146-7882-4421-997b-153594e84a77
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|
| 35372 | Analgesic transcutaneous electrical nerve stimulation system | An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20754756740010 | GS1 | 8 | In Commercial Distribution | ||
| Package | 10754756740013 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 00754756740016 | GS1 |
Customer Contacts
- Phone
- 407-770-0710
- [email protected]