Duns Number:005036025
Device Description: The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical di The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software. This Kit contains the IQcal® 3-Litre Calibration Syringe.
Catalog Number
4-000-0026
Brand Name
Midmark IQspiro® Digital Spirometer with Calibration Syringe
Version/Model Number
4-000-0026
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
-
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
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
bd105fac-2234-45dd-b8b0-735ed00a9212
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
September 24, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |