QuinGas - QUINGAS, BREATHTRACKER CALIBRATION - QUINTRON INSTRUMENT COMPANY, INC.

Duns Number:874498744

Device Description: QUINGAS, BREATHTRACKER CALIBRATION

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More Product Details

Catalog Number

QT07500-G

Brand Name

QuinGas

Version/Model Number

QT07500-G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BXK

Product Code Name

Gas, Calibration (Specified Concentration)

Device Record Status

Public Device Record Key

6f688021-ad0c-43fb-a951-acd17e7c5987

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUINTRON INSTRUMENT COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6