Duns Number:533108028
Catalog Number
12000-000-0028
Brand Name
AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE,
Version/Model Number
12000-000-0028
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
9b35d46a-a99c-4a48-b400-e8a5c6632fae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
27290109150523
Quantity per Package
20
Contains DI Package
17290109150526
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cardboard box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |