Duns Number:788403103
Device Description: The IBC Mini Sucker is a component of Blood Recovery Suction Systems for use in open heart The IBC Mini Sucker 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 Mini Sucker (Non Sterile)
Version/Model Number
1980N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2018
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,K963756
Product Code
DTS
Product Code Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Public Device Record Key
fb3a5cd7-256e-4d86-b9ad-a62fe72e9d4a
Public Version Date
April 20, 2020
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 |