Duns Number:533108028
Catalog Number
12000-000-0044
Brand Name
AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDELESS Y-SITE
Version/Model Number
12000-000-0044
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
K123049,K123049
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
cc9b79c8-a1ed-4981-b164-e8043bc63996
Public Version Date
June 25, 2019
Public Version Number
1
DI Record Publish Date
June 17, 2019
Package DI Number
27290109159205
Quantity per Package
20
Contains DI Package
17290109159208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboardbox
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |