Duns Number:080935429
Device Description: Drainage Bag with Catheter,14 Fr/Ch (4.7 mm), 5 mL Hydrogel Coated Catheter Pre-connected Drainage Bag with Catheter,14 Fr/Ch (4.7 mm), 5 mL Hydrogel Coated Catheter Pre-connected to 2000 mL Drainage Bag, Luer-Lock Sampling with Top Vent, Anti-Reflux Device, Drain Spout
Catalog Number
FPP14UL
Brand Name
Dover
Version/Model Number
FPP14UL
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)
Yes
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
694e68bf-b3e1-455f-b9cd-472015c6c14a
Public Version Date
December 04, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
20884521046716
Quantity per Package
20
Contains DI Package
10884521046719
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 |