Duns Number:658620117
Device Description: 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit
Catalog Number
-
Brand Name
FortisCare Self-Monitoring Blood Glucose System
Version/Model Number
EM66
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
ecef23a2-41e5-4546-8555-28363b93a42f
Public Version Date
May 22, 2018
Public Version Number
3
DI Record Publish Date
July 24, 2016
Package DI Number
01885017000460
Quantity per Package
10
Contains DI Package
00885017000461
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 |