Duns Number:004217071
Device Description: Pediatric Intracardiac Sucker Tip - 4.0 mm diameter. For use with the Round Pediatric Han Pediatric Intracardiac Sucker Tip - 4.0 mm diameter. For use with the Round Pediatric Handle 30 Degree Angle (1450JR-01), the Round Pediatric Handle 90 Degree Angle (1450JR-01-90), and Flat Pediatric Handle 40 Degree Angle (1470JR-01)
Catalog Number
1450-16
Brand Name
PEMCO INC
Version/Model Number
1450-16
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
418cf772-0064-4c09-9e0e-07e68b58f0d8
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 |