Duns Number:216643186
Device Description: Enteral, Drainage Bag, PVC, Single Use 2000ml
Catalog Number
DBP-2000
Brand Name
Enteral
Version/Model Number
DBP-2000
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"
-
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
c6452e03-6893-45c1-a4dc-5fede3957c59
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 14, 2022
Package DI Number
05060590880937
Quantity per Package
4
Contains DI Package
05060590880920
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Peel Pack
| 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 |