Duns Number:082005361
Catalog Number
-
Brand Name
CADD
Version/Model Number
21-7044-24
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
K942046,K942046
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
18f8a0e5-6e92-49c5-bc96-3a02bc0bb769
Public Version Date
January 07, 2020
Public Version Number
1
DI Record Publish Date
December 30, 2019
Package DI Number
35019517184208
Quantity per Package
25
Contains DI Package
15019517184204
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 9371 |