FDA.reportPublic FDA data

HARVEST® BMAC®

Primary DI
05020583514294
Brand
HARVEST® BMAC®
Company
TERUMO BCT, INC.
Model
51429
Device description
Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120n Bone Marrow Procedure Pack
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
FMFSyringe, piston
JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103340000SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEMHarvest Technologies, Corp.2010-12-06JQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05020583514294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05020583514294050205835142945020583514294

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)339-4228FDAUDIprogram@terumobct.com

Regulatory Flags#

DUNS number
801679200
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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05020583826663Trima Accel® 826662017-02-15
05020583700512Blood Component Sampling Sets700512016-09-15
05020583803565Trima Accel® 803562017-02-15
05020583804401Trima Accel® 804402016-09-15
05020583824409Trima Accel® 824402016-09-15
05020583803503Trima Accel® 803502016-09-15
05020583803701Trima Accel® 803702016-09-15
05020583803404Trima Accel® 803402016-09-15
05020583803602Trima Accel® 803602016-09-15
05020583807006Trima Accel® 807002016-09-15
05020583804500Trima Accel® 804502016-09-15
05020583805002Trima Accel® 805002016-09-15

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