Duns Number:042928915
Device Description: 18” (46cm) Standard bore extension set with roller clamp, 1 needleless connector, male lue 18” (46cm) Standard bore extension set with roller clamp, 1 needleless connector, male luer-lock and female luer
Catalog Number
-
Brand Name
FK20225E
Version/Model Number
FK20225E
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
172b435b-c0ff-4e12-b8db-b2eb1fb8946d
Public Version Date
March 29, 2019
Public Version Number
1
DI Record Publish Date
March 21, 2019
Package DI Number
20850005864060
Quantity per Package
100
Contains DI Package
00850005864066
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 |