Duns Number:315654579
Device Description: ATO Oxygenator line is a tubing system to connect an oxygenator with one fourth inch male ATO Oxygenator line is a tubing system to connect an oxygenator with one fourth inch male connector to an Autotransfusion device.
Catalog Number
9108434
Brand Name
ATO Oxygenator line
Version/Model Number
9108434
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
-
Product Code
CAC
Product Code Name
Apparatus, Autotransfusion
Public Device Record Key
9822e2bc-e4d0-4e12-a41b-86ea2bf22b2e
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000645
Quantity per Package
20
Contains DI Package
04052682000638
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |