Duns Number:038000253
Device Description: 5F X 10CM BREEZE STRAIGHT5F X 10 LUER LOCK CENTESISLUER LOCK CENT DRAINAGE CATHETERDRAINAG 5F X 10CM BREEZE STRAIGHT5F X 10 LUER LOCK CENTESISLUER LOCK CENT DRAINAGE CATHETERDRAINAGE CATHET
Catalog Number
-
Brand Name
BREEZE CENTESIS DRAINAGE CATHETERBREEZE CENTESIS DRAINAGE CATHETER
Version/Model Number
CESLL5100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 19, 2022
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
cd89f5a4-d285-4762-9d69-a8e5a4a32778
Public Version Date
January 20, 2022
Public Version Number
3
DI Record Publish Date
December 30, 2017
Package DI Number
50884908131074
Quantity per Package
10
Contains DI Package
00884908131079
Package Discontinue Date
January 19, 2022
Package Status
Not 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 |