3CP™ Centrifuge

GUDID 05714188021577

Haematological concentrate system centrifuge

Primary Device ID	05714188021577
NIH Device Record Key	8f0babc5-e2f6-4d21-91f2-2b25421350c9
Commercial Distribution Status	In Commercial Distribution
Brand Name	3CP™ Centrifuge
Version Model Number	1
Company DUNS	312293991
Company Name	Reapplix ApS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	05714188021577 [Primary]

JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
PMQ	Peripheral Blood Processing Device For Wound Management

Steralize Prior To Use	false
Device Is Sterile	false

05714188301808 - 3CP™ Counterbalance	2019-05-31 Used with 3CP Centrifuge to counterbalance weight of 3C Patch Device(s).
05714188308005 - 3CP™ Centrifuge Kit	2019-05-31 Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display prot
05714188501000 - 3C Patch® Needle Holder	2019-05-31 Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
05714188502106 - 3C Patch® Device	2019-05-31 Holds the blood at collection and during processing in the centrifuge.
05714188505008 - 3C Patch® Kit	2019-05-31 Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Al
05714188505206 - Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set	2019-05-31 This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holde
05714188505503 - 3C Patch® Kit - Box	2019-05-31 This is the outer label for the box that includes 12 3C Patch Kits and the IFU.
05714188505602 - 3C Patch® Device - Extra Component Set	2019-05-31 This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.