Duns Number:037690120
Device Description: Spirometer
Catalog Number
SIB301
Brand Name
Astra Spirometer
Version/Model Number
300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 2020
Issuing Agency
In HIBCC
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
K061571
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
32dcb6cc-1558-4469-a47c-83f428d79e5f
Public Version Date
March 08, 2022
Public Version Number
6
DI Record Publish Date
September 21, 2016
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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 102 |