FDA UDI
In Commercial Distribution
🇺🇸 United States
Detecto
DI: 00809161201901
·
Model: WPS12DT
·
CARDINAL SCALE MANUFACTURING COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Detecto
- Primary DI
- 00809161201901
- Version / Model
- WPS12DT
- Company Name
- CARDINAL SCALE MANUFACTURING COMPANY
- Labeler DUNS
- 007153505
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 1cbf7f73-dc6b-4b79-b482-58e84d6dab0c
Device Description
Wet Diaper Scale, Mariner Waterproof IP67, 12-lb capacity, 7.5" X 9.75"
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
- 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 |
|---|---|---|---|---|
| FQA | Scale, Surgical Sponge | General Hospital | 880.2740 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40494 | Medical/surgical procedure scale, electronic | An electronic device designed to weigh body tissues and/or clinical objects [e.g., dressings, surgical sponges, nappies (diapers)] in association with a medical/surgical procedure and/or at autopsy. It is not intended to weigh a patient (including infants), and is not intended for laboratory use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00809161201901 | GS1 |