Duns Number:176458115
Device Description: A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for testing bl A blood glucose meter for use with AimStrip® Plus Blood Glucose Test Strips for testing blood glucose levels.
Catalog Number
-
Brand Name
AIMSTRIP PLUS BLOOD GLUCOSE METER, BOX KIT
Version/Model Number
37321
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
-
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
b5efc267-34b7-48d7-8d95-f6c4aa041e90
Public Version Date
September 29, 2022
Public Version Number
3
DI Record Publish Date
April 27, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |