SMART M-CELL Bone Marrow Concentration System

Primary DI
08809286201086
Brand
SMART M-CELL Bone Marrow Concentration System
Company
Miracell Co., Ltd.
Model
BmSC+3 240
Device description
The SMART M-CELL Bone Marrow Concentration System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of a cell concentrate from bone marrow.
Published
2026-10-16
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

Product Codes#

Code, Name table
CodeName
QBVCentrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBVCentrifuge For Preparation Of Cell Concentrate And/Or Plasma ConcentrateClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250518000SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.2026-04-02QBV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809286201086PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809286201086088092862010868809286201086

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, bone marrow concentrationA collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device.

Regulatory Flags#

DUNS number
688266575
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809286201024SMART M-CELL PRP Concentration SystemBSC+3 302026-10-16
08809286201031SMART M-CELL PRP Concentration SystemBSC+3 602026-10-16
08809286201048SMART M-CELL PRP Concentration SystemBSC+3 1202026-10-16
08809286201055SMART M-CELL PRP Concentration SystemBSC+3 2402026-10-16
08809286201062SMART M-CELL Bone Marrow Concentration SystemBmSC+3 602026-10-16
08809286201079SMART M-CELL Bone Marrow Concentration SystemBmSC+3 1202026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809286201024SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.QBV2026-10-16
08809286201031SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.QBV2026-10-16
08809286201048SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.QBV2026-10-16
08809286201055SMART M-CELL PRP Concentration SystemMiracell Co., Ltd.QBV2026-10-16
08809286201062SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.QBV2026-10-16
08809286201079SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd.QBV2026-10-16
G0561068421PDQ Platelet CentrifugeBio/Data CorporationQBV2023-08-30
04050674075572ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674076302ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674076326ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674076333ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02
04050674082532ROTIXA 500 RSAndreas Hettich GmbHQBV2021-09-02