Duns Number:080935429
Device Description: Hydrogel Coated Latex Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connecte Hydrogel Coated Latex Urine Meter Foley Tray,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Needle Sampling
Catalog Number
2016
Brand Name
Dover
Version/Model Number
2016
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FCM
Product Code Name
Tray, catheterization, sterile urethral, with or without catheter (kit)
Public Device Record Key
66e14d1f-6e1e-4de7-b9fc-81bc7b8d378f
Public Version Date
February 23, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521015170
Quantity per Package
10
Contains DI Package
10884521015173
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 |