Duns Number:315654579
Device Description: PSQ Set comprises:1. a storage bag for PRP and plasma including connection lines for the r PSQ Set comprises:1. a storage bag for PRP and plasma including connection lines for the reinfusion bag of the AT1 Autotransfusion Set (=PRC bag) and for the waste line2. an adapter for connecting the standard blood bag to the blood inlet line of the AT1 Autotransfusion Set3. a separate reservoir connection line.
Catalog Number
9005144
Brand Name
PSQ Set
Version/Model Number
9005144
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
3623b915-077d-40d1-b384-2847c63caf4a
Public Version Date
March 24, 2021
Public Version Number
6
DI Record Publish Date
September 01, 2015
Package DI Number
04052682000478
Quantity per Package
16
Contains DI Package
04052682000461
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 |