Duns Number:356164426
Device Description: HemoCue Glucose 201 Analyzer mg/dL plasma
Catalog Number
120706
Brand Name
HemoCue® Glucose 201 Analyzer
Version/Model Number
120706
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
K020935
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
4c1bc9c7-f8ff-452a-84a8-19281cce6f89
Public Version Date
October 31, 2022
Public Version Number
4
DI Record Publish Date
May 31, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |