Duns Number:421062164
Catalog Number
-
Brand Name
Infusion Set for Single Use
Version/Model Number
AD0501
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162601,K162601,K162601
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
24e8309c-6b95-4266-a98d-7197aca4fa0b
Public Version Date
October 10, 2022
Public Version Number
5
DI Record Publish Date
January 15, 2018
Package DI Number
06970440020286
Quantity per Package
6
Contains DI Package
06970440020095
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-