Duns Number:658637244
Device Description: The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of c The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control solution(00883489001580),10 pcs/set of lancet(Sterile)(00883489001597) and 10 pcs/vial of strips_iGlucose Strip(00883489001573).
Catalog Number
99GM291I01
Brand Name
ODM
Version/Model Number
iGlucose Blood Glucose Monitoring System
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161790,K161790,K161790,K161790,K161790,K161790,K161790,K161790,K161790
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
24bd8864-462f-451d-80ea-dc478ffab99e
Public Version Date
January 06, 2020
Public Version Number
4
DI Record Publish Date
July 19, 2017
Package DI Number
00883489001580
Quantity per Package
1
Contains DI Package
00883489001504
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
combo
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |