FDA UDI
In Commercial Distribution
🇺🇸 United States
HIVADOT
DI: 00092237623473
·
Model: DO1009
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HIVADOT
- Primary DI
- 00092237623473
- Version / Model
- DO1009
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-07
- Public Version
- 2
- Public Version Date
- 2023-09-06
- Public Version Status
- Update
- Public Device Record Key
- d9443b04-61d5-4883-9a58-bca751a46185
Device Description
Hivadot with accessories, deep oscillation device
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
- No
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45168 | Static magnetic massager | A hand-held device designed to be moved over body surfaces that uses static magnets (e.g., rotating magnetic balls) intended to produce a weak magnetic flux over a superficial body site to provide comfort and localized temporary relief from minor aches and pains. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 80092237623479 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00092237623473 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]