FDA.reportPublic FDA data

XCELL

Primary DI
B708XCBMC300
Brand
XCELL
Company
APEX BIOLOGIX , LLC
Model
XC-BMC-30
Device description
XCELL Bone Marrow Aspirate Concentrating System 30ml XC-BMC-30
Published
2023-05-18
Public version status
New
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
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B708XCBMC301PackageHIBCC10In Commercial Distribution
B708XCBMC300PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
079560357
Device count
1
Premarket exempt
true
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
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
B708XCPRPBV60NS1XCELLXC-PRP-BV-60NS2025-01-24
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
10850044310262Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310279Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310309Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
00810052864990Boost 2 Flex DC Centrifuge, RevanceDRUCKER DIAGNOSTICSJQC2026-05-11
00810052865003Boost 4 Centrifuge, Pointiva MedicalDRUCKER DIAGNOSTICSJQC2026-05-11
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00810052864976TrueBond TriFLEX Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2026-04-29
10850044310323Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310347Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310354Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310422Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310224Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
10850044310248Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
00860015460660Nextgen CentrifugeT AESTHETICS LLCJQC2026-04-02
00810052863016DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00840095681674Globe ScientificGLOBE SCIENTIFIC INC.JQC2026-03-16
10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310293Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310378Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310392Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310484Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310491Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02
00664816006016LW ScientificLW SCIENTIFIC, INC.JQC2026-02-20
00664816005682LW Scientific, Inc.LW SCIENTIFIC, INC.JQC2026-02-16
00810052864945642M Centrifuge, AccuReferenceDRUCKER DIAGNOSTICSJQC2026-02-02
00810052864938TrueBond Set 3 Centrifuge, ZoetisDRUCKER DIAGNOSTICSJQC2026-01-15
G668FG0020ASCENT FLEXXBMCORTHOASCENT, LLCJQC2026-01-05