FDA UDI
In Commercial Distribution
🇺🇸 United States
RICHMAR
DI: 00092237617342
·
Model: WQ6005PLUG
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
Basic Information
- Brand Name
- RICHMAR
- Primary DI
- 00092237617342
- Version / Model
- WQ6005PLUG
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 3
- Public Version Date
- 2023-08-07
- Public Version Status
- Update
- Public Device Record Key
- b315929a-5f67-42fd-8309-852acae96e57
Device Description
Lead Wires for Quattro 2/2.5 &
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35751 | Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 80092237617348 | GS1 | CA | 100 | In Commercial Distribution | |
| Primary | 00092237617342 | GS1 | ||||
| Unit of Use | 01092237617341 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]