FDA UDI
In Commercial Distribution
🇺🇸 United States
Na (Sodium) Electrode
DI: 04580262010260
·
Model: 20-27-0474
·
TOKYO BOEKI MEDISYS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Na (Sodium) Electrode
- Primary DI
- 04580262010260
- Version / Model
- 20-27-0474
- Catalog Number
- 20-27-0474
- Company Name
- TOKYO BOEKI MEDISYS INC.
- Labeler DUNS
- 696265656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-30
- Public Version
- 7
- Public Version Date
- 2024-02-01
- Public Version Status
- Update
- Public Device Record Key
- 86e82a66-6051-43b2-aed7-c3b523ad3488
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 |
|---|---|---|---|---|
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | 862.1665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59249 | Sodium (Na+) electrode IVD | An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04580262010260 | GS1 |
Customer Contacts
- Phone
- +81425872965
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040958 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius