FDA UDI
In Commercial Distribution
🇺🇸 United States
Capintec Dose Calibrator
DI: 00859942006072
·
Model: CRC-PC Smart Chamber HL Chamber
·
Mirion Technologies (capintec), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Capintec Dose Calibrator
- Primary DI
- 00859942006072
- Version / Model
- CRC-PC Smart Chamber HL Chamber
- Catalog Number
- 5130-20253
- Company Name
- Mirion Technologies (capintec), Inc.
- Labeler DUNS
- 047684501
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 4
- Public Version Date
- 2022-12-14
- Public Version Status
- Update
- Public Device Record Key
- 0029ee52-4adb-4662-bdc0-5c54f21c070f
Device Description
Radioisotope Dose Calibrator
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
- 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 |
|---|---|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | Radiology | 892.1360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40738 | Radioisotope calibration system | A system of radioactivity measuring instruments designed for quantifying the amount of radiation in a radiopharmaceutical dose or other test samples inserted into a shielded chamber or well for measurement. The system's instruments radiation level measurements in units of Curie and/or Becquerel are used to quantify the radioactivity in diagnostic or therapeutic radiopharmaceuticals prior to and after patient administration. This will be used to measure radiation levels of in vitro diagnostic test samples, e.g., those required for Schilling tests, Cr-51 or I-125 blood volume. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859942006072 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141413 | 000 |