Duns Number:094439676
Device Description: SeroVac® Drain, With Needle, With Connection Tubing
Catalog Number
-
Brand Name
Axiom® SeroVac®
Version/Model Number
214
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
K965146,K965146,K965146
Product Code
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
430d3dae-cb20-4bb4-bc01-03b02fbeb91a
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2018
Package DI Number
M6652143
Quantity per Package
10
Contains DI Package
M6652141
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 187 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |