FDA UDI
In Commercial Distribution
🇺🇸 United States
Huamei
DI: 06973512860544
·
Model: HM-C500
·
Shandong Huamei Technology Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Huamei
- Primary DI
- 06973512860544
- Version / Model
- HM-C500
- Company Name
- Shandong Huamei Technology Co.,Ltd.
- Labeler DUNS
- 540583132
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-04
- Public Version
- 1
- Public Version Date
- 2020-11-12
- Public Version Status
- New
- Public Device Record Key
- 2b76a4a4-30db-441d-91d6-0ba6a9fccd4f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 63679 | Liquid-jet skin surface treatment system control unit | An electrically-powered, mobile (on wheels) device intended to create a high-pressure aerosol of liquid (e.g., water, saline, herbal solution) for application to the skin for cosmetic skin treatment procedures (e.g., skin rejuvenation, facial deep cleansing, reduction of hair loss, removal of scars). It consists of a main unit with air/liquid pumps, a user-interface and controls, and is used with a dedicated applicator (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06973512860544 | GS1 |