Duns Number:169260325
Device Description: 8" Standardbore Extension Set with 0.2 Micron Filter & Slide Clamp
Catalog Number
-
Brand Name
IV Plus
Version/Model Number
N0080A
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
K890176,K890176
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
e9de51c8-781c-4d88-bd76-3c15d6c0c5d1
Public Version Date
January 17, 2022
Public Version Number
1
DI Record Publish Date
January 07, 2022
Package DI Number
30815879021404
Quantity per Package
50
Contains DI Package
10815879021400
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 180 |