Duns Number:080028910
Device Description: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
Catalog Number
1468A
Brand Name
BREEZE® 2
Version/Model Number
1468A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 05, 2018
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
K062347,K062347,K062347,K062347,K062347
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
985e522a-ed9d-41b3-b3c7-7b6d72b9ed47
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40301931468500
Quantity per Package
24
Contains DI Package
00301931468502
Package Discontinue Date
February 05, 2018
Package Status
Not in Commercial Distribution
Package Type
shipper/case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |