Duns Number:004217071
Device Description: Perfusion Cannula. Small Handle 7.5 inches long. Style # 10 Fixed Tip with side holes - Perfusion Cannula. Small Handle 7.5 inches long. Style # 10 Fixed Tip with side holes - 1 MM Tip Diameter. 145 Degree Bend.Also available in: Large, Flag, & Tube Handle Styles
Catalog Number
1580-P-10-1MM-145
Brand Name
PEMCO INC
Version/Model Number
1580-P-10-1MM-145
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
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
c3deae45-5a2d-424f-9efd-0013014c4605
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 26, 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 |