Duns Number:118380146
Device Description: MicroClave™ Connector
Catalog Number
011-C3300
Brand Name
ICU Medical
Version/Model Number
011-C3300
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
K970855,K970855
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
401fb131-487c-4ceb-84f6-05053670faf4
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
10840619001428
Quantity per Package
100
Contains DI Package
00840619001421
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 |