Duns Number:008171162
Device Description: The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measureme The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. For single-patient use only.
Catalog Number
-
Brand Name
GLUCOCARD® W Blood Glucose Monitoring System
Version/Model Number
511100
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
K170064,K170064
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
52e8e01e-f180-417e-ba0c-8083854e082a
Public Version Date
April 09, 2019
Public Version Number
1
DI Record Publish Date
April 01, 2019
Package DI Number
10015482511101
Quantity per Package
4
Contains DI Package
00015482511104
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |