Duns Number:485050483
Device Description: Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the re Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases.
Catalog Number
ORO1H
Brand Name
Pall® Oxygenator Gas Line Filter
Version/Model Number
ORO1H
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"
Yes
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
-
Product Code
JQC
Product Code Name
CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
Public Device Record Key
9ed37a22-2a66-41dd-85ef-5fa11917fe1e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 20, 2016
Package DI Number
35034480000447
Quantity per Package
40
Contains DI Package
05034480000446
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |