FDA UDI
In Commercial Distribution
🇺🇸 United States
Yumizen C1200 Phosphate
DI: 03610230007143
·
Model: 1300023862
·
HORIBA ABX SAS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Yumizen C1200 Phosphate
- Primary DI
- 03610230007143
- Version / Model
- 1300023862
- Company Name
- HORIBA ABX SAS
- Labeler DUNS
- 273647420
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-13
- Public Version
- 2
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 596e8b8c-3a4e-48c6-a4a7-445e44e8ce65
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | Clinical Chemistry | 862.1580 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59123 | Inorganic phosphate (PO43-) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03610230007143 | GS1 |