FDA UDI
In Commercial Distribution
🇺🇸 United States
PHOENIX DIAGNOSTICS, INC.
DI: 00853366007202
·
Model: 16-227
·
PHOENIX DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PHOENIX DIAGNOSTICS, INC.
- Primary DI
- 00853366007202
- Version / Model
- 16-227
- Company Name
- PHOENIX DIAGNOSTICS, INC.
- Labeler DUNS
- 606814960
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-26
- Public Version
- 4
- Public Version Date
- 2020-03-30
- Public Version Status
- Update
- Public Device Record Key
- 882048f0-4223-4f2d-8950-63c168e2c93e
Device Description
ISE 1N KCL Sol for Roche / Hitachi 911 Series Chemistry Systems
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
- No
- 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 |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59238 | Ion selective electrode (ISE) reference solution IVD, reagent | A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10853366007209 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 00853366007202 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013451 | 000 |