FDA UDI
In Commercial Distribution
🇺🇸 United States
Detecto
DI: 00809161323504
·
Model: 6856-C
·
CARDINAL SCALE MANUFACTURING COMPANY
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Detecto
- Primary DI
- 00809161323504
- Version / Model
- 6856-C
- Company Name
- CARDINAL SCALE MANUFACTURING COMPANY
- Labeler DUNS
- 007153505
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-18
- Public Version
- 1
- Public Version Date
- 2021-11-26
- Public Version Status
- New
- Public Device Record Key
- 917321ea-74fa-4838-aae2-dfa188bb9a0a
Device Description
Bariatric Scale, Digital, 1000 lb x .2 lb / 450kg x .1 kg, 24" x 24" Platform, BT / WiFi
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 |
| 33255 | Chair scale, electronic | A battery-powered device designed for weighing elderly and/or weak patients, patients with a disability, or patients undergoing a specific treatment (e.g., dialysis) who are unable to use a conventional floor scale. It is the form of a chair in which the patient sits and their weight subsequently measured and displayed. It is primarily used for routine patient weight checks, but is also used to continuously and accurately monitor body fluid gain and loss in dialysis patients. It is designed to provide accurate patient weight measurements regardless of patient position in the chair seat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00809161323504 | GS1 |