Duns Number:788403103
Device Description: The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in open hear The IBC Suction Wand is a component of Blood Recovery Suction Systems for use in open heart procedures, autologus blood recovery or blood suction. It is a disposable, single use component.
Catalog Number
-
Brand Name
IBC Suction Wand (Sterile)
Version/Model Number
1990S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
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"
-
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
K963756
Product Code
DTS
Product Code Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Public Device Record Key
931ff0fb-0bdd-43ce-b295-b7849c2670e7
Public Version Date
December 14, 2021
Public Version Number
7
DI Record Publish Date
July 11, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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. | 22 |