FDA UDI
In Commercial Distribution
🇺🇸 United States
Well at Walgreens
DI: 00311917159928
·
Model: FG9301
·
WALGREEN CO.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Well at Walgreens
- Primary DI
- 00311917159928
- Version / Model
- FG9301
- Company Name
- WALGREEN CO.
- Labeler DUNS
- 008965063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 8988f8dd-bc44-4b9c-a934-c210cdd95c59
Device Description
Digital glass scale with body analysis features.
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MNW | Analyzer, Body Composition | Cardiovascular | 870.2770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36022 | Bioelectrical body composition analyser | An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10311917159925 | GS1 | Case | 4 | Not in Commercial Distribution | 2016-10-19 |
| Primary | 00311917159928 | GS1 |
Customer Contacts
- Phone
- 1-877-365-6274
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Area/Surface Area | 90000 | Square millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius