Duns Number:004217071
Device Description: Intracardiac Sucker Set with two Tips – Round, Pediatric Flat at 40 Degree Angle. Comes w Intracardiac Sucker Set with two Tips – Round, Pediatric Flat at 40 Degree Angle. Comes with Pediatric Tips 1450-15 6.4 mm diameter, 1450-16 4.0 mm diameter. Also fits 1450-17 2.0mm diameter & 1450-17L 2.0mm diameter long. 1450-15 Tip is grooved and slotted to allow for better flow and prevent clogging. Suckers have 5/16" barbed end. * Handles and tips may be ordered as separate items.
Catalog Number
1470JR
Brand Name
PEMCO INC
Version/Model Number
1470JR
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
359e103b-5ee9-4574-83a5-8f4dfa8d2101
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 |