Duns Number:016898496
Device Description: Mid-stream Urine Collector with Rigid Funnel and Benzalkonium Chloride Towelettes
Catalog Number
842801
Brand Name
Midstream Urine Collector
Version/Model Number
842801
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 13, 2021
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
cdd1311c-680f-49af-bfc4-ccd9106aa390
Public Version Date
December 09, 2021
Public Version Number
2
DI Record Publish Date
October 21, 2020
Package DI Number
10801741051194
Quantity per Package
50
Contains DI Package
00801741051197
Package Discontinue Date
October 13, 2021
Package Status
Not in Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |