Duns Number:118380146
Device Description: Lifeshield™ Primary PLUM™ Set 15 Micron Filter in Sight Chamber, CLAVE™ Secondary Port, CL Lifeshield™ Primary PLUM™ Set 15 Micron Filter in Sight Chamber, CLAVE™ Secondary Port, CLAVE™ Y-Site, Secure Lock272 cm / 19 mL
Catalog Number
14001
Brand Name
ICU Medical
Version/Model Number
14001
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
K141789,K141789
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
54574657-3ee8-4534-83fb-aec5bf7a8054
Public Version Date
November 03, 2021
Public Version Number
1
DI Record Publish Date
October 26, 2021
Package DI Number
30887709100122
Quantity per Package
50
Contains DI Package
00887709100121
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 |