Duns Number:080935429
Device Description: 100% Silicone Silver-Hydrogel Coated Urine Meter Foley Tray with Coude Tip,16 Fr/Ch (5.3 m 100% Silicone Silver-Hydrogel Coated Urine Meter Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 400 mL Urine Meter with 2000 mL Drainage Bag with Adhesive Catheter Securem
Catalog Number
P4P16XCSDK
Brand Name
Dover
Version/Model Number
P4P16XCSDK
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCN
Product Code Name
Urinary drainage collection kit, for indwelling catheter
Public Device Record Key
757b6c2e-c287-44a0-b2bc-747b50a07dca
Public Version Date
December 04, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521176482
Quantity per Package
10
Contains DI Package
10884521176485
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |