Duns Number:004217071
Device Description: Intracardiac Sucker, Pediatric Flat Handle at 40 Degree Angle has 5/16" barbed end. Works Intracardiac Sucker, Pediatric Flat Handle at 40 Degree Angle has 5/16" barbed end. Works with the following tips Tips 1450-15 6.4mm diameter, 1450-16 4.0mm diameter, 1450-17 2.0mm diameter, & 1450-17L 2.0mm diameter (long)
Catalog Number
1470JR-01
Brand Name
PEMCO INC
Version/Model Number
1470JR-01
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
6309aa68-d6da-4ad2-8483-4008772d5c0d
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 |