Duns Number:626132575
Device Description: The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing lab The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking. The device is composed of two integrally-attached processing and storage containers (or a single processing container) with separation media.
Catalog Number
P/N PCB2100-270
Brand Name
PrepaCyte-CB
Version/Model Number
PCB2100-270
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
OAO
Product Code Name
Cord Blood Processing System And Storage Container
Public Device Record Key
9f63526d-551f-4c38-9c7f-b16231ee918e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |