Duns Number:080935429
Device Description: 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 m 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor
Catalog Number
P4P18XTS
Brand Name
Dover
Version/Model Number
P4P18XTS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZL
Product Code Name
CATHETER, RETENTION TYPE, BALLOON
Public Device Record Key
675c34bc-3214-4e1f-bf89-c41156e709f7
Public Version Date
December 04, 2020
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
20884521069074
Quantity per Package
10
Contains DI Package
10884521069077
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 |