FDA UDI
In Commercial Distribution
🇺🇸 United States
Health o meter Professional
DI: 00892076002176
·
Model: 1522KL
·
Pelstar, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Health o meter Professional
- Primary DI
- 00892076002176
- Version / Model
- 1522KL
- Company Name
- Pelstar, LLC
- Labeler DUNS
- 037289290
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-10
- Public Version
- 1
- Public Version Date
- 2022-01-18
- Public Version Status
- New
- Public Device Record Key
- c1867278-bdd3-426f-aa51-dc1015a6ad3e
Device Description
Pediatric Beam Scale with Tray
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 |
|---|---|---|---|---|
| 36817 | Infant scale, mechanical | A mechanical device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes during critical care procedures. It typically consists of a weight tray, a beam lever system mounted on a hardened steel pivot point, and a sliding weight(s) that can be moved along the weight scale to indicate the occupant's weight when it is in balance. The device is also known as a paediatric or baby scale. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00892076002176 | GS1 |