Duns Number:695318717
Device Description: The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
Catalog Number
-
Brand Name
POCone Infrared Spectrophotometer
Version/Model Number
POCone
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K041148
Product Code
JJQ
Product Code Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Public Device Record Key
e70075ce-a2d5-4d3e-a4f3-229a090f0d84
Public Version Date
November 07, 2019
Public Version Number
1
DI Record Publish Date
October 30, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |