Duns Number:236289299
Device Description: The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for p The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature.
Catalog Number
XCMOP405PMP
Brand Name
Paragon Adult Maxi PMP Oxygenator
Version/Model Number
XCMOP405PMP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191246,K191246
Product Code
DTZ
Product Code Name
Oxygenator, Cardiopulmonary Bypass
Public Device Record Key
abbb5db8-4cb1-4958-bf89-91968686b36c
Public Version Date
January 28, 2021
Public Version Number
1
DI Record Publish Date
January 20, 2021
Package DI Number
15060491617912
Quantity per Package
12
Contains DI Package
05060491617915
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX