Duns Number:658637244
Device Description: one box contained 2 meter kitbox and 8 50pcs-strip box.
Catalog Number
-
Brand Name
GE
Version/Model Number
333
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
Yes
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
5bce8e18-6db0-4091-9065-5eee237994f4
Public Version Date
December 03, 2018
Public Version Number
1
DI Record Publish Date
October 31, 2018
Package DI Number
20883489310433
Quantity per Package
12
Contains DI Package
10883489310436
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| 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 |