Duns Number:080028910
Device Description: Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 1030193 Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
Catalog Number
7283
Brand Name
CONTOUR® NEXT
Version/Model Number
7283
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P160017,P150001,K162336,K160430,K121190,K121190,K160430,K162336,P150001,P160017,K121190,K160430,K162336,P150001,P160017
Product Code
LFR
Product Code Name
Glucose Dehydrogenase, Glucose
Public Device Record Key
b1653fc7-fb56-4f31-b79e-5f24d1376209
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
40301937283350
Quantity per Package
12
Contains DI Package
00301937283352
Package Discontinue Date
October 24, 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 |