Duns Number:004217071
Device Description: Intracardiac Sucker, Adult Round Handle at 90 Degree Angle has 3/8" & 1/2" barbed end. Wo Intracardiac Sucker, Adult Round Handle at 90 Degree Angle has 3/8" & 1/2" barbed end. Works with the following tips 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, and 1480-03 7.0 mm diameter.
Catalog Number
1450-01-90
Brand Name
PEMCO INC
Version/Model Number
1450-01-90
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
34042ae3-ae6c-422f-87e6-d184f44ed785
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 |