Duns Number:315654579
Device Description: ATR 40 Reservoir is a 3 Liter collection reservoir containing a 40 µm filter, designated t ATR 40 Reservoir is a 3 Liter collection reservoir containing a 40 µm filter, designated to collect, defoam, filter and store blood prior to processing.
Catalog Number
9108414
Brand Name
ATR 40 Autotransfusion Reservoir
Version/Model Number
9108414
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
DTN
Product Code Name
Reservoir, Blood, Cardiopulmonary Bypass
Public Device Record Key
ab357b5b-e667-46f6-8541-815abad50a58
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000492
Quantity per Package
8
Contains DI Package
04052682000485
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 |