FDA UDI
In Commercial Distribution
🇺🇸 United States
BodyTrace
DI: B726BT0060
·
Model: BT006
·
BODYTRACE, INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- BodyTrace
- Primary DI
- B726BT0060
- Version / Model
- BT006
- Company Name
- BODYTRACE, INC
- Labeler DUNS
- 116841525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-03
- Public Version
- 1
- Public Version Date
- 2021-11-11
- Public Version Status
- New
- Public Device Record Key
- e4df48df-1409-40d2-9c73-f7479af2a7b7
Device Description
Weight scale.
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | B726BT0061 | HIBCC | Individual box | 1 | In Commercial Distribution | |
| Primary | B726BT0060 | HIBCC | ||||
| Package | B726BT0062 | HIBCC | 5-piece carton | 5 | In Commercial Distribution |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 80 – 105 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 80 – 105 KiloPascal