Duns Number:080935429
Device Description: 100 percent Silicone Silver Hydrogel Coated Urine Meter Foley Tray with Coude Tip
Catalog Number
P4P18XCSDK2
Brand Name
Dover
Version/Model Number
none
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
41ef1251-af36-4ccf-b2a5-0b28384b0049
Public Version Date
September 30, 2021
Public Version Number
2
DI Record Publish Date
March 17, 2021
Package DI Number
50885380176713
Quantity per Package
10
Contains DI Package
10885380176715
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 |