Duns Number:006261481
Device Description: CUSTOM PACK BB11U84R5 4PK ADVENTHEALTH
Catalog Number
-
Brand Name
NA
Version/Model Number
BB11U84R5
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171979,K171979
Product Code
DWF
Product Code Name
Catheter, cannula and tubing, vascular, cardiopulmonary bypass
Public Device Record Key
5b1b2740-a44c-4f94-88ea-d16cea81ae77
Public Version Date
October 11, 2022
Public Version Number
1
DI Record Publish Date
October 03, 2022
Package DI Number
20763000746043
Quantity per Package
4
Contains DI Package
00763000746032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |