FDA UDI
In Commercial Distribution
🇺🇸 United States
206 Electrometer
DI: 00862246000301
·
Model: 206
·
CNMC CO., INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- 206 Electrometer
- Primary DI
- 00862246000301
- Version / Model
- 206
- Catalog Number
- 206
- Company Name
- CNMC CO., INC.
- Labeler DUNS
- 128639556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-07
- Public Version
- 1
- Public Version Date
- 2020-02-17
- Public Version Status
- New
- Public Device Record Key
- 8f7d1563-1f01-47b8-9440-00b2a09e964c
Device Description
The CNMC Model 206 is a medical dosimeter or medical electrometer that is capable of performing measurements of diagnostic and therapeutic amounts of ionizing radiation when an appropriate ionization chamber or diode dosimeter is connected.
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
- No
- Has Manufacturing Date
- No
- 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 | 00862246000301 | GS1 | ||||
| Previous | 08622460003012 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150265 | 000 |