Duns Number:176387785
Catalog Number
-
Brand Name
microlife
Version/Model Number
Model: b990655-2 Office ABI
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
116ab8e4-1e0a-485a-998a-5fd152236b91
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
May 19, 2017
Package DI Number
16970388169129
Quantity per Package
8
Contains DI Package
06970388169122
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton packing
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |