Duns Number:080028910
Device Description: Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0 Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - NDC # 0193-7090-21).
Catalog Number
7080G
Brand Name
CONTOUR®
Version/Model Number
7080G
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062058,K062058,K062058,K062058,K062058,K062058,K062058,K062058,K062058,K062058
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
806f9ad7-8f79-4fef-8a6a-1023a14a3476
Public Version Date
August 02, 2021
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40301939727210
Quantity per Package
12
Contains DI Package
00301937090219
Package Discontinue Date
July 31, 2017
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 |