Duns Number:369263660
Catalog Number
-
Brand Name
M914, Medikro® Primo
Version/Model Number
M9492
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
cb044e7e-a99f-43f9-b6c7-8e80f35a437b
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
July 13, 2018
Package DI Number
06420099000516
Quantity per Package
1
Contains DI Package
06420099000851
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |