Duns Number:038000253
Device Description: 8F X 20CM BREEZE® ALL PURPOSE DRAIN WITH LOCKING MINI PIGTAIL SET
Catalog Number
BALMN0820S
Brand Name
BREEZE® APD
Version/Model Number
BALMN0820S
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGE
Product Code Name
Stents, drains and dilators for the biliary ducts
Public Device Record Key
614f027b-e1b4-44e5-bd02-779734756043
Public Version Date
March 07, 2022
Public Version Number
1
DI Record Publish Date
February 26, 2022
Package DI Number
50884908139049
Quantity per Package
20
Contains DI Package
30884908139045
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |