Duns Number:618825723
Device Description: VOMIT AND URINE BLUE BAG (EMESIS) WITH RIGID PLASTIC COLLAR AND NOTCHES TO SECURE TWISTED VOMIT AND URINE BLUE BAG (EMESIS) WITH RIGID PLASTIC COLLAR AND NOTCHES TO SECURE TWISTED BAG FROM LEAKING.
Catalog Number
404085
Brand Name
KENTEX
Version/Model Number
404085
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
Yes
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
e24135c3-76cf-41f5-97a9-c3221ea64237
Public Version Date
December 19, 2018
Public Version Number
1
DI Record Publish Date
November 18, 2018
Package DI Number
00810003751256
Quantity per Package
24
Contains DI Package
00810003751249
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER PACK
| 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 |