Duns Number:118380146
Device Description: 7" (18 cm) Appx 0.43 ml, Pressure Infusion (400psig) Ext Set w/Clave™ Clear, Priming Cap, 7" (18 cm) Appx 0.43 ml, Pressure Infusion (400psig) Ext Set w/Clave™ Clear, Priming Cap, Purple Clamp, Rotating Luer
Catalog Number
MC33131PC
Brand Name
ICU Medical
Version/Model Number
MC33131PC
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
K100576,K100576
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
77bea5f3-e083-4051-bd81-5d5b5192073a
Public Version Date
August 30, 2021
Public Version Number
1
DI Record Publish Date
August 20, 2021
Package DI Number
10887709121673
Quantity per Package
50
Contains DI Package
00887709121676
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |