FDA UDI
In Commercial Distribution
🇺🇸 United States
Potassium Electrode
DI: 00811403010127
·
Model: AV-BP0359D
·
Diamond Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Potassium Electrode
- Primary DI
- 00811403010127
- Version / Model
- AV-BP0359D
- Company Name
- Diamond Diagnostics Inc.
- Labeler DUNS
- 947514303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-05
- Public Version
- 1
- Public Version Date
- 2023-06-13
- Public Version Status
- New
- Public Device Record Key
- 622c1711-0ea2-4e53-a238-cce9b53cc077
Device Description
Measuring concentration of Potassium in whole blood, serum, plasma, and diluted urine samples.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | 862.1600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59248 | Potassium (K+) electrode IVD | An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811403010127 | GS1 |