Duns Number:013861471
Device Description: 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set (4 Sites)
Catalog Number
SCIG33136
Brand Name
Clear-View Multi-site Subcutaneous Infusion Set
Version/Model Number
ClearView™MS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K870188
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
c46e2cd7-f7d3-4719-9349-358c448c14d1
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 239 |