FDA.reportPublic FDA data

XCELL

Primary DI
B708XCPRPBV600
Brand
XCELL
Company
APEX BIOLOGIX , LLC
Model
XC-PRP-BV-60
Device description
XCELL Platelet Concentrating System 60mL Convenience Kit (PN 90-018) created for Bioventus incorporating XC-PRP-60 (PN 90-001) and ACD-A (PN 70-111)
Published
2025-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ORGPlatelet And Plasma Separator For Bone Graft Handling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B708XCPRPBV601PackageHIBCC10In Commercial Distribution
B708XCPRPBV600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
844-897-4910orders@apexbiologix.com

Regulatory Flags#

DUNS number
079560357
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B708XCPRPBV60EV0XCELLXC-PRP-BV-60EV2025-01-24
B708XCPRPBV60NS0XCELLXC-PRP-BV-60NS2025-01-24
B708ABFVR020XCELLAB-FVR-022026-03-26
B708XCPC120XCELLXC-PC-1202026-03-26
B708XCPC60XCELLXC-PC-602026-03-26
B708ACDA130XCELLACD-A-132025-03-10
B708ACDA200XCELLACD-A-202025-03-10
B708XCPRPBV601XCELLXC-PRP-BV-602025-01-24
B708XCPRPBV60EV1XCELLXC-PRP-BV-60EV2025-01-24
B708XCPRPBV60NS1XCELLXC-PRP-BV-60NS2025-01-24
B708XCBMC300XCELL XC-BMC-302023-05-18
B708XCBMC301XCELL XC-BMC-302023-05-18
B708XCPRP300XCELLXC-PRP-302023-05-18
B708XCPSPC1200XCELLXC-PSPC-1202022-11-16
B708XCPSPC1201XCELLXC-PSPC-1202022-11-16
B708XCBMASC600XCELL XC-BMA-SC-602022-04-18
B708XCBMCSC600XCELLXC-BMC-SC-602022-04-18
B708XCBMSC600XCELL XC-BMSC-602022-04-18
B708XCBMASC601XCELL XC-BMA-SC-602022-04-18
B708XCBMCSC601XCELLXC-BMC-SC-602022-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08685139210029Centrifuge Container SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-04-10
00850083564001MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564025MARGENIXBahia Medical Inc.ORG2026-04-03
00850083564049GoldrushBahia Medical Inc.ORG2026-04-03
00850083564056GoldrushBahia Medical Inc.ORG2026-04-03
00850083564063GenesisBahia Medical Inc.ORG2026-04-03
00850023741561CERVOS PLATELET SEPARATOR 80 KITRANFAC CORP.ORG2026-03-30
00850075308088CER-PRP-160 STERILITY PACKRANFAC CORP.ORG2026-03-30
00850075308101CER-PRP-160 KitRANFAC CORP.ORG2026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILERANFAC CORP.ORG2026-03-30
B708XCPC120XCELLAPEX BIOLOGIX , LLCORG2026-03-26
B708XCPC60XCELLAPEX BIOLOGIX , LLCORG2026-03-26
00850033131215RegenKit®-BCT-T-URegenlab USA LLCORG2026-03-25
08685139210036Exocube SetEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210012ExoCubeEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08685139210067ExoCube-20PackEXOCUBE BIYOTEKNOLOJI ANONIM SIRKETIORG2026-03-15
08809410200046Dr.PRPRmedica Co.,LtdORG2026-02-02
08809410200053Dr.PRPRmedica Co.,LtdORG2026-02-02
G668FG0010ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
G668FG0011ASCENT FLEXXPRP ORTHOASCENT, LLCORG2026-01-05
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFIDIA FARMACEUTICI SPAORG2025-10-31
00850075308095CER-PRP-SINGLE-ARANFAC CORP.ORG2025-10-08
04719875912245Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
04719875912252Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912242Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
14719875912259Transcend PRPAEON BIOTHERAPEUTICS CORP.ORG2025-08-07
00850075308118Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
10850075308115Cervos Platelet Separator Triple Pack B2RANFAC CORP.ORG2025-07-23
08435389829089ENDORET KITBIOTECHNOLOGY INSTITUTE SLORG2025-06-03
04719875912122Virtue CPKitAEON BIOTHERAPEUTICS CORP.ORG2025-05-15