Duns Number:118380146
Device Description: Primary PLUM Set, CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 128 Primary PLUM Set, CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 128 Inch
Catalog Number
15951-28
Brand Name
ICU Medical
Version/Model Number
15951-28
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
K141789,K141789
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
3ad805ac-799c-431f-b0ab-c811ca8ea8a5
Public Version Date
September 21, 2022
Public Version Number
1
DI Record Publish Date
September 13, 2022
Package DI Number
10887709102474
Quantity per Package
48
Contains DI Package
00887709102477
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |