Duns Number:042928915
Device Description: 18” (46cm) Standard bore extension set with 1.2 Micron Filter, pinch clamp, male lure-lock 18” (46cm) Standard bore extension set with 1.2 Micron Filter, pinch clamp, male lure-lock and female luer
Catalog Number
-
Brand Name
FK20255E
Version/Model Number
FK20255E
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
1f7b72f5-ce19-4794-8f12-11afdefe7113
Public Version Date
April 05, 2019
Public Version Number
1
DI Record Publish Date
March 28, 2019
Package DI Number
10850005864193
Quantity per Package
100
Contains DI Package
00850005864196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |