FDA UDI
In Commercial Distribution
🇺🇸 United States
PC Electrometer Reference Class Dual-Channel Electrometer (BNC)
DI: 05060608880065
·
Model: 1014300Z
·
SUN NUCLEAR CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PC Electrometer Reference Class Dual-Channel Electrometer (BNC)
- Primary DI
- 05060608880065
- Version / Model
- 1014300Z
- Catalog Number
- 1014000-0Z
- Company Name
- SUN NUCLEAR CORP.
- Labeler DUNS
- 122240021
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-05
- Public Version
- 2
- Public Version Date
- 2019-04-05
- Public Version Status
- Update
- Public Device Record Key
- d996ca38-82eb-4e42-9233-03ee9669aec9
Device Description
Radiation therapy QA device.
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
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 | 05060608880065 | GS1 | ||||
| Previous | B01610140000Z0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092019 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Before storage, install caps on both detector inputs. The input connector interior has high impedance; the caps protect the inputs from contamination which could cause increased leakage current.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 18.7 – 106 KiloPascal