Duns Number:315654579
Device Description: Reinfusion bag with Y-adapter contains a reinfusion bag and a Y-adapter to connect 2 reinf Reinfusion bag with Y-adapter contains a reinfusion bag and a Y-adapter to connect 2 reinfusion bags to the Packed Red Cells line.
Catalog Number
9005164
Brand Name
Reinfusion bag with Y-adapter
Version/Model Number
9005164
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
b8d70f78-2b64-4dcb-b13c-81ede62e3616
Public Version Date
March 24, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000591
Quantity per Package
20
Contains DI Package
04052682000584
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 |