FDA UDI
In Commercial Distribution
🇺🇸 United States
Reliefband® Conductivity Gel
DI: 00661168190011
·
Model: GP-1
·
RELIEFBAND TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reliefband® Conductivity Gel
- Primary DI
- 00661168190011
- Version / Model
- GP-1
- Catalog Number
- GP-1
- Company Name
- RELIEFBAND TECHNOLOGIES LLC
- Labeler DUNS
- 080294073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-29
- Public Version
- 1
- Public Version Date
- 2021-07-07
- Public Version Status
- New
- Public Device Record Key
- 09858be8-7784-4960-854c-8e0d036b48d6
Device Description
Reliefband Conductivity Gel for use with Reliefband devices. Each tube contains 7.5 mL (0.25 oz) of hypoallergenic conductivity gel. Reliefband Conductivity Gel improves effectiveness of Reliefband devices, keeping nerve stimulation active to control nausea and vomiting associated with motion sickness, morning sickness, chemotherapy and postoperative.
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
- No
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63388 | Anti-nausea transcutaneous electrical nerve stimulation wristband | An electrically-powered device designed to be worn on the wrist of a patient to apply electrical stimuli to the median nerve through the skin (transcutaneously), to help relieve the sensation of nausea caused by various conditions [e.g., pregnancy (morning sickness), motion (travel sickness), chemotherapy]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00661168190011 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]