Duns Number:013861471
Device Description: 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set w/ Male-to-Male Adapter (3 Site 27G x 6mm x 36" Clear-View Multi-site "Sub-Q" Infusion Set w/ Male-to-Male Adapter (3 Sites)
Catalog Number
SCIG43135AM
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,K870188
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
3a0facc8-55ad-4717-bbf3-03f9481197d7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 2016
Package DI Number
M991SCIG43135AM2
Quantity per Package
6
Contains DI Package
M991SCIG43135AM1
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. | 239 |