Duns Number:618825723
Device Description: VOMIT AND URINE WHITE BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" WIDE RIGID OPENING A VOMIT AND URINE WHITE BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6" WIDE RIGID OPENING AT THE TOP.
Catalog Number
404087
Brand Name
KENOREX
Version/Model Number
404087
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FNY
Product Code Name
Basin, Emesis
Public Device Record Key
72a85db3-ab20-426a-a257-5e16401424d2
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
00810003751201
Quantity per Package
20
Contains DI Package
00810003751195
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |