Duns Number:176387785
Catalog Number
-
Brand Name
microlife
Version/Model Number
PF101
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZH
Product Code Name
Meter, Peak Flow, Spirometry
Public Device Record Key
c996de5f-75eb-4a18-842b-c37baa41849c
Public Version Date
June 10, 2022
Public Version Number
1
DI Record Publish Date
June 02, 2022
Package DI Number
10642632732057
Quantity per Package
2
Contains DI Package
00642632732050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box packing
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |