FDA UDI
In Commercial Distribution
🇺🇸 United States
pO2 Electrode
DI: 00811403017690
·
Model: RD-945376D
·
Diamond Diagnostics Inc.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- pO2 Electrode
- Primary DI
- 00811403017690
- Version / Model
- RD-945376D
- Company Name
- Diamond Diagnostics Inc.
- Labeler DUNS
- 947514303
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 79eeea1f-e51d-439c-83a0-db65e0b9c055
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54501 | Blood gas pO2 IVD, kit, ion-selective electrode (ISE) | A collection of reagents and other associated materials intended to be used for the quantitative measurement of blood gas partial pressure of oxygen (pO2) using an ion-selective electrode (ISE) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811403017690 | GS1 |