Duns Number:136941411
Device Description: Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1 Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)
Catalog Number
-
Brand Name
On Call Express Blood Glucose Monitoring System
Version/Model Number
G115-10D
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
4a3b43f7-7933-4605-b221-aff18d1729ff
Public Version Date
April 07, 2020
Public Version Number
1
DI Record Publish Date
March 30, 2020
Package DI Number
10024291121838
Quantity per Package
3
Contains DI Package
00024291121831
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON