Duns Number:004135503
Device Description: Retail Blood Glucose Test Strips for Clever Choice HD and Voice HD Blood Glucose Meters.
Catalog Number
62850-0000-22
Brand Name
Pharmacist's Choice
Version/Model Number
Test Strips - Retail
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
0fb0b776-a8db-42f0-9ece-19d5b1ce02b4
Public Version Date
October 09, 2019
Public Version Number
4
DI Record Publish Date
August 12, 2016
Package DI Number
10898302140220
Quantity per Package
40
Contains DI Package
00898302140223
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |