Duns Number:004217071
Device Description: Intracardiac Sucker Set with four Tips - Round, Adult Handle at 30 Degree Angle. Comes wi Intracardiac Sucker Set with four Tips - Round, Adult Handle at 30 Degree Angle. Comes with Adult Tips 1450-05 10.5 mm diameter, 1450-06 8.8 mm diameter, 1450-07 8.0 mm diameter, 1450-08 6.4 mm diameter; can also use 1480-03 7.0 mm diameter tip. NOTE: All tips also fit 1480-04 sucker handle. Tips are grooved and slotted to allow for better flow and prevent clogging. Suckers have 3/8" & 1/2" barbed end. * Handles and tips may be ordered as separate items..
Catalog Number
1450
Brand Name
PEMCO INC
Version/Model Number
1450
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTS
Product Code Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Public Device Record Key
6e8b4ef7-c555-4c63-b821-e284269dec90
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 19, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 160 |