Duns Number:058027475
Device Description: Trifurcated Swan-Lock Needle-Free Extension Set with a 0.2 Micron Filter
Catalog Number
-
Brand Name
Codan
Version/Model Number
BC 239N
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)
-
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
681dc13b-158f-4a1a-8a13-2c901ca4d41e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 30, 2017
Package DI Number
00897891001915
Quantity per Package
1
Contains DI Package
10897891001912
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. | 381 |