Duns Number:658620117
Device Description: a bottle of level 1 control solution
Catalog Number
-
Brand Name
EM 15 Blood Glucose Level 1 Control Solution
Version/Model Number
EM44
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
a77b84f5-e674-496d-82a0-6a071f6bed3b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 12, 2016
Package DI Number
01885017000361
Quantity per Package
12
Contains DI Package
00885017000362
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 |