FDA.reportPublic FDA data

XCELL

Primary DI
B708XCPRPBV60NS1
Brand
XCELL
Company
APEX BIOLOGIX , LLC
Model
XC-PRP-BV-60NS
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) This is a non-sterile configuration
Published
2025-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B708XCPRPBV60NS1PackageHIBCC10In Commercial Distribution
B708XCPRPBV60NS0PrimaryHIBCC0

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079560357
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B708XCPRPBV600XCELLXC-PRP-BV-602025-01-24
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
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

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