Duns Number:080028910
Device Description: Control Solution - Level 1. 1 x 2.5 mL.
Catalog Number
7315
Brand Name
CONTOUR® NEXT
Version/Model Number
7315
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
K121190,K151742,K121190,K151742,K121190,K151742,K121190,K151742
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
1b0add37-248b-4793-b13c-160612f45feb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
50301937315010
Quantity per Package
32
Contains DI Package
40301937315013
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 |