Duns Number:080028910
Device Description: Control Solution - High, 1 x 2.5 mL
Catalog Number
7111B
Brand Name
CONTOUR®
Version/Model Number
7111B
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
K062058,K090628,K062058,K090628,K062058,K090628,K062058,K090628
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
18bea87a-b73a-41ff-822e-a03088d6f273
Public Version Date
December 03, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50301937111018
Quantity per Package
32
Contains DI Package
40301937111011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
out.shipper/lg.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 |