| 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 |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com | |
| Phone | +4588168066 |
| info@reapplix.com |
| 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 |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-20 |
| Device Publish Date | 2018-07-19 |
| 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. |