FDA.reportPublic FDA data

HARVEST®

Primary DI
05020583514010
Brand
HARVEST®
Company
TERUMO BCT, INC.
Model
51401
Device description
Platelet Concentrate (PC) 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
ORGPlatelet and plasma separator for bone graft handling

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1200380

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1200380

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35020583514011PackageGS14In Commercial Distribution
05020583514010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3502058351401135020583514011
05020583514010050205835140105020583514010

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system preparation kit, platelet concentrationA collection of sterile 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 typically includes a blood withdrawal set, tubes, and syringes. 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. The glue-like product is applied to the surface of the injured tissue or bone where its adherent properties form a haemostatic barrier and enhance regeneration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05020583103108Spectra Optia®103102016-09-15
05020583610002Spectra Optia®610002016-09-15
05020583001145Reveos® Automated Whole Blood Processing System240002025-08-06
05020583826502Trima Accel826502023-06-19
05020583803664Trima Accel® 803662017-02-15
05020583804005Trima Accel®804002016-09-15
05020583824089Trima Accel® 824082016-09-15
05020583826601Trima Accel® 826602016-09-15
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

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