FDA UDI
In Commercial Distribution
🇺🇸 United States
Doran Scales
DI: 00850013361083
·
Model: DS4500
·
DORAN SCALES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Doran Scales
- Primary DI
- 00850013361083
- Version / Model
- DS4500
- Catalog Number
- DS4500
- 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
- 5c3490cf-3e48-47a6-a18c-ddcdb7eebd8e
Device Description
Digital Baby Lactation Scale, 45lbx0.1oz (20kgx2g) includes ULc approved 100-240 VAC 50/60Hz 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 |
|---|---|---|---|---|
| FRW | Scale, Patient | General Hospital | 880.2720 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35324 | Infant scale, electronic | An electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850013361083 | GS1 |
Customer Contacts
- Phone
- 630-879-1200
- [email protected]