Duns Number:197201572
Device Description: Kova System Pac II (Urinalysis package containing 400 plastic tubes, 400 plastic pipettes, Kova System Pac II (Urinalysis package containing 400 plastic tubes, 400 plastic pipettes, and 100 4-chambered plastic microscope slides without gridlines)
Catalog Number
87155 / 87155E
Brand Name
Kova Plastics
Version/Model Number
87155
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNW
Product Code Name
Bag, Urine Collection, Leg, For External Use, Non-Sterile
Public Device Record Key
ac2517d8-b888-48ae-984f-01308162f9bd
Public Version Date
May 13, 2022
Public Version Number
3
DI Record Publish Date
July 29, 2021
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |