DEVICE: Capintec Dose Calibrator (00589942006089)

Device Identifier (DI) Information

Capintec Dose Calibrator
CRC-PC Smart Chamber RPh Chamber
In Commercial Distribution
5130-20254
CAPINTEC, INC.
00589942006089
GS1

1
047684501 *Terms of Use
Radioisotope Dose Calibrator
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
KPT Calibrator, Dose, Radionuclide
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0ae3f68d-13a2-4804-8310-fe22909c9169
March 29, 2018
2
September 27, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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