Duns Number:080028910
Device Description: Control Solution - Normal, 1 x 2.5 mL
Catalog Number
7109B
Brand Name
CONTOUR®
Version/Model Number
7109B
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090628,K062058,K090628,K062058,K062058,K090628,K062058,K090628
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
4d135aa0-eb49-4352-91ae-8c063b5901b2
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
00301937109010
Quantity per Package
1
Contains DI Package
10301937109017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| 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 |