FDA.reportPublic FDA data

3CP™ Centrifuge

Primary DI
05714188021577
Brand
3CP™ Centrifuge
Company
Reapplix ApS
Model
1
Device description
This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge that creates the output (i.e., PRP).
Published
2018-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
PMQPeripheral Blood Processing Device For Wound Management

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1
PMQPeripheral Blood Processing Device For Wound ManagementHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1700020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1700020

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714188021577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714188021577057141880215775714188021577

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system centrifugeA mains electricity (AC-powered) device typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm) from a small volume of autologous (patient's own) blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may be a tabletop or floor unit; may include refrigeration.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4588168066info@reapplix.com

Regulatory Flags#

DUNS number
312293991
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
057141883018083CP™ Counterbalance22019-05-23
057141883080053CP™ Centrifuge Kit22019-05-23
057141885010003C Patch® Needle Holder22019-05-23
057141885021063C Patch® Device22019-05-23
057141885050083C Patch® Kit22019-05-23
057141885052064 x (21G Needle + 3C Patch® Needle Holder)22019-05-23
05714188505503Box - 3C Patch® Kit22019-05-23
057141885056023C Patch® Device - Extra Component Set22019-05-23
057141883080673CP™ Centrifuge Kit12019-04-03
057141883018223CP™ Counterbalance12018-07-19
057141883080503CP™ Centrifuge Kit12018-07-19
057141885010933C Patch® Needle Holder12018-07-19
057141885021513C Patch® Device12018-07-19
057141885050463C Patch® Kit12018-07-19
05714188505220Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set12019-01-09
057141885055413C Patch® Kit - Box12018-07-19
057141885056193C Patch® Device - Extra Component Set12019-01-09

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