FDA UDI
In Commercial Distribution
🇺🇸 United States
Detecto
DI: 00809161335507
·
Model: 6855MHR-AC-1K
·
CARDINAL SCALE MANUFACTURING COMPANY
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Detecto
- Primary DI
- 00809161335507
- Version / Model
- 6855MHR-AC-1K
- Company Name
- CARDINAL SCALE MANUFACTURING COMPANY
- Labeler DUNS
- 007153505
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-19
- Public Version
- 1
- Public Version Date
- 2022-09-27
- Public Version Status
- New
- Public Device Record Key
- e8ee7e60-7e0a-48a7-9ba6-e810d17ba733
Device Description
Bariatric Scale, Digital, 1000lb x .2lb / 270kg x .1kg, 18" x 14" Platform, AC Adapter, Height Rod
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 |
| 37001 | Patient-height measure | A device designed to measure the height of a patient. It can be, e.g., a wall-mounted graduated scale or a freestanding vertical graduated rod with an adjustable cross-piece that is placed on the top of the patient's head. It may provide analogue or digital readings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00809161335507 | GS1 |