Duns Number:118380146
Device Description: Secondary Set Polyethlyene-Lined Resistant Tubing, Secure Lock, 40 Inch
Catalog Number
14234-01
Brand Name
ICU Medical
Version/Model Number
14234-01
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
K142433,K142433
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
485c90d3-a3c9-4bc1-a056-6c9af394cde2
Public Version Date
October 27, 2021
Public Version Number
1
DI Record Publish Date
October 19, 2021
Package DI Number
10887709102016
Quantity per Package
50
Contains DI Package
00887709102019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4887 |