Duns Number:831996595
Device Description: Used for calibrating analyzers that are used in testing related to pulmonary functions, ca Used for calibrating analyzers that are used in testing related to pulmonary functions, cardiac output, and metabolic studies.
Catalog Number
Pulmonary Function Gas
Brand Name
Airgas Healthcare
Version/Model Number
Device Gas
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BXK
Product Code Name
Gas, Calibration (Specified Concentration)
Public Device Record Key
9b890d0a-91f8-4636-a35d-6a6669d52c28
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 01, 2018
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 | 281 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |