Duns Number:315654579
Device Description: ATF 120 Fast Start Kit is a kit consisting of AT1, ATR 120 Autotransfusion reservoir and t ATF 120 Fast Start Kit is a kit consisting of AT1, ATR 120 Autotransfusion reservoir and the ATS Suction Line.
Catalog Number
9108504
Brand Name
ATF 120 Fast Start Kit
Version/Model Number
9108504
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
a8c4a032-da0a-45d9-90a1-cab98360914f
Public Version Date
March 30, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000706
Quantity per Package
4
Contains DI Package
04052682000690
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 |