FDA.reportPublic FDA data

AcCELLerated Biologics PURE PRP II 60mL GenesisCS Component Concentrating System

Primary DI
00855306003503
Brand
AcCELLerated Biologics PURE PRP II 60mL GenesisCS Component Concentrating System
Company
EMCYTE CORP.
Model
AB60-PURE
Catalog number
AB60-PURE
Published
2019-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0500550
K024080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0500550
K024080000SECQUIRE CELL SEPARATORPerfusion Partners & Assoc., Inc.2003-07-02JQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855306003503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855306003503008553060035038553060035030855306003503

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 Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(239)482-7725support@emcyte.com

Regulatory Flags#

DUNS number
021599728
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855306003688PurePRP Supraphysiologic 30mL GenesisCS Component Concentrating SystemGS30-SPGS30-SP2019-01-08
00855306003695PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating SystemGS60-SPGS60-SP2019-01-08
00855306003701PurePRP Supraphysiologic 120mL GenesisCS Component Concentrating SystemGS120-SPGS120-SP2019-01-08
00855306003008AbsolutePRP 60mL GenesisCS Component Concentrating SystemGS60GS602019-01-08
00855306003015Accelerate Platelet Concentrating System 60mL620-11-02620-11-022019-01-08
00855306003022Accelerate Platelet Concentrating System PRP-S 30mL620-11-07620-11-072019-01-08
00855306003039Accelerate Platelet Concentrating System PRP-S 30mL620-11-06620-11-062019-01-08
00855306003046Accelerate Platelet Concentrating System PRP-S 60mL620-11-08620-11-082019-01-08
00855306003053Concentrating System PRP-S 60mL GenesisCS Component Concentrating System620-11-09620-11-092019-01-08
00855306003084AbsolutePRP 120mL GenesisCS Component Concentrating SystemGS120GS1202019-01-08
00855306003091AbsoluteBMC 120mL GenesisCS Component Concentrating SystemGSBMA-120GSBMA-1202019-01-08
00855306003107AbsoluteBMC 60mL GenesisCS Component Concentrating SystemGSBMA-60GSBMA-602019-01-08
00855306003183PurePRP 60mL GenesisCS Component Concentrating SystemGS60-PUREGS60-PURE2019-01-08
00855306003190AbsolutePRP 30mL GenesisCS Component Concentrating SystemGS30GS302019-01-08
00855306003244Cyclone Bone Marrow Concentration System 60mLCYC-60-01CYC-60-012019-01-08
00855306003251Cyclone Bone Marrow Concentration System 120mLCYC-120-01CYC-120-012019-01-08
00855306003268Accelerate II Bone Marrow Concentrating System 60mL620-32-34620-32-342019-01-08
00855306003275Accelerate II Bone Marrow Concentrating System 120mL620-32-36620-32-362019-01-08
00855306003299Accelerate II Platelet Concentrating System PRP-S 30mL620-22-06620-22-062019-01-08
00855306003305Accelerate II Platelet Concentrating System PRP-S 30mL620-22-07620-22-072019-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874104928Life PRP LLCLife PRP, LLCJQC2026-05-30
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
00810052864983DASH Pro 24 Centrifuge, DruckerDRUCKER DIAGNOSTICSJQC2026-05-04
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