FDA UDI
In Commercial Distribution
🇺🇸 United States
Doran Scales
DI: 00850013361267
·
Model: PC400-05
·
DORAN SCALES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Doran Scales
- Primary DI
- 00850013361267
- Version / Model
- PC400-05
- Catalog Number
- PC400-05
- Company Name
- DORAN SCALES, INC.
- Labeler DUNS
- 021437579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-31
- Public Version
- 1
- Public Version Date
- 2022-06-08
- Public Version Status
- New
- Public Device Record Key
- 7e1cc785-9e03-4fdb-bd23-af705e080761
Device Description
Diaper and Specimen Scale 5x0.002lb (2300x1g) includes ULc approved, 110 VAC adapter
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 |
|---|---|---|---|---|
| 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 | 00850013361267 | GS1 |
Customer Contacts
- Phone
- 630-879-1200
- [email protected]