FDA UDI
In Commercial Distribution
🇺🇸 United States
MH
DI: 00850018327916
·
Model: MH-Y526
·
MAZZA HEALTHCARE LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MH
- Primary DI
- 00850018327916
- Version / Model
- MH-Y526
- Company Name
- MAZZA HEALTHCARE LLC
- Labeler DUNS
- 830069063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-27
- Public Version
- 1
- Public Version Date
- 2023-01-04
- Public Version Status
- New
- Public Device Record Key
- f8f93408-4388-42af-b31e-cea7ee79368f
Device Description
Digital Pediatric Scale
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 10850018327913 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00850018327916 | GS1 |