FDA UDI
In Commercial Distribution
🇺🇸 United States
Standard Imaging CDX 2000B Electrometer
DI: 00850019946079
·
Model: 90001
·
STANDARD IMAGING INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Standard Imaging CDX 2000B Electrometer
- Primary DI
- 00850019946079
- Version / Model
- 90001
- Catalog Number
- 90001
- Company Name
- STANDARD IMAGING INC.
- Labeler DUNS
- 788084705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-22
- Public Version
- 1
- Public Version Date
- 2023-06-30
- Public Version Status
- New
- Public Device Record Key
- 8aeb6fb7-2694-425a-b409-78e9a4569d63
Device Description
Standard Imaging CDX 2000B Electrometer is a portable electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36596 | Radiation electrometer | A stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850019946079 | GS1 |