Duns Number:658620117
Device Description: 1 bottle of Level 2 Solution
Catalog Number
-
Brand Name
EasyMax NHCS Set EN
Version/Model Number
EasyMax
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
e533c087-b60a-47c6-a752-4eae424207df
Public Version Date
July 01, 2020
Public Version Number
1
DI Record Publish Date
June 23, 2020
Package DI Number
10885017000550
Quantity per Package
192
Contains DI Package
00885017000553
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |