Duns Number:938289980
Device Description: A collection of sterile, flexible, double-bore tubing, and associated items (typically inc A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.
Catalog Number
201095-000
Brand Name
Aortic Sump Set - Adult
Version/Model Number
201095-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K801392,K801392,K801392,K801392,K801392
Product Code
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
85c2a8b6-7c82-4489-962d-993a5d6fb6b1
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
September 26, 2016
Package DI Number
B0662010950006
Quantity per Package
100
Contains DI Package
B0662010950000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |