Duns Number:315654579
Device Description: ATR Cap Set is a reserve cap set for the ATR 40 or ATR 120 Autotransfusion reservoir.
Catalog Number
9108574
Brand Name
ATR CAP SET
Version/Model Number
9108574
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
cfce4441-85c0-4f63-9934-0ca2ce5f7186
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000775
Quantity per Package
75
Contains DI Package
04052682000768
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 |