Duns Number:556115970
Device Description: Sterile IV Administration Set 15Dr/ml 100" With Injection Site.
Catalog Number
-
Brand Name
Oasis
Version/Model Number
IV15
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"
-
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
5dd0c7f5-5859-4d5f-bf5f-01647843e79c
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
August 05, 2016
Package DI Number
B031IV151
Quantity per Package
50
Contains DI Package
B031IV150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |