Duns Number:859323297
Device Description: Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level Liquid Urine Control - Level 1/Level 2, 10 ml. Contains 3 vials Level 1 and 3 vials Level 2. 18 month open vial stability when stored at 2-8° C.
Catalog Number
323-16-12
Brand Name
NA
Version/Model Number
323-16-12
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K890577
Product Code
JJW
Product Code Name
Urinalysis Controls (Assayed And Unassayed)
Public Device Record Key
0b33c3bd-ee7c-4f5b-b718-a13c238751ec
Public Version Date
April 08, 2019
Public Version Number
1
DI Record Publish Date
March 29, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |