Duns Number:216643186
Device Description: Enteral ISOSAF Single Use Drainage Bag 500ml
Catalog Number
DBP-500HT
Brand Name
Enteral
Version/Model Number
DBP-500HT
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FFD
Product Code Name
EVACUATOR, BLADDER, MANUALLY OPERATED
Public Device Record Key
67fac7aa-5604-48ea-9a5f-c7073a121ac3
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
05060590889428
Quantity per Package
4
Contains DI Package
05060590889411
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |