Duns Number:658637244
Device Description: The combination products includes 2 boxes(00883489001207) of meters(00883489001191) and 8 The combination products includes 2 boxes(00883489001207) of meters(00883489001191) and 8 boxes(00883489001245) of strips(00883489001238)
Catalog Number
99GM555CZ1
Brand Name
GE
Version/Model Number
GE100
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
K092052,K092052
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
20af4ecc-3ece-4561-8870-dab8f0f11952
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 20, 2017
Package DI Number
20883489084846
Quantity per Package
12
Contains DI Package
10883489084849
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| 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 |