FDA UDI
In Commercial Distribution
🇺🇸 United States
GoWISE USA
DI: 00853821006368
·
Model: GW22040
·
MING'S MARK INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- GoWISE USA
- Primary DI
- 00853821006368
- Version / Model
- GW22040
- Company Name
- MING'S MARK INC.
- Labeler DUNS
- 005175432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 524ecf48-39ea-4554-97ae-1161122e5e51
Device Description
GoWISE USA Digital Body Fat Scale - Measures Weight, Body Fat, Water & Bone Mass, 400 lbs Capacity, Tempered Glass (Lavender)
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRI | Scale, Stand-On, Patient | General Hospital | 880.2700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38211 | Stand-on floor scale, electronic | An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20853821006362 | GS1 | Pallet | 4 | In Commercial Distribution | |
| Package | 10853821006365 | GS1 | Case | 1 | In Commercial Distribution | |
| Primary | 00853821006368 | GS1 |