FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Uni-Patch
DI: 20192253018292
·
Model: 1504
·
Cardinal Health 200, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- Uni-Patch
- Primary DI
- 20192253018292
- Version / Model
- 1504
- Catalog Number
- EP84179
- Company Name
- Cardinal Health 200, LLC
- Labeler DUNS
- 961027315
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2024-02-28
- Public Version
- 3
- Public Version Date
- 2025-03-31
- Public Version Status
- Update
- Public Device Record Key
- 33e44099-1d56-4dcd-aaf0-a1ecdef8fd4e
- Distribution End Date
- 2025-03-31
Device Description
Uni-Patch™ S Series Stimulating Electrodes
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| DRX | Electrode, electrocardiograph | Cardiovascular | 870.2360 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 10192253018295 | GS1 | ||||
| Primary | 20192253018292 | GS1 | ||||
| Package | 90192253018291 | GS1 | CASE | 1 | Not in Commercial Distribution | 2025-03-30 |