FDA.reportPublic FDA data

Sepax RM

Primary DI
07640125650594
Brand
Sepax RM
Company
Biosafe S.A.
Model
Sepax RM
Catalog number
14100
Published
2016-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07640125650594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640125650594076401256505947640125650594

GMDN Terms#

Term, Definition table
TermDefinition
Blood centrifugation system processing unitA mains electricity (AC-powered) portable device that is a component of a blood centrifugation system designed for the automated processing of blood, relative components or cellular products (e.g., umbilical cord blood, bone marrow), in a closed sterile environment using centrifugation to isolate constituent components (e.g., cells, plasma). It is a programmable device with an integral centrifuge intended to provide centrifugal and axial displacement drive to a centrifugation chamber, as well as drive to directional valves that control the flow of blood components to collection bags. The device is not donor or patient connected.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41223652727support.biosafe@ge.com
+41848802810ordersch@cytiva.com

Regulatory Flags#

DUNS number
488052341
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640125650150Stem Cell Banking-Single-use kitsCS-530.4100242016-09-18
07640125650198Stem Cell Banking-Single-use kitsCS-540.4100252016-09-18
07640125650440Kit ConnectorKit Connector70332016-09-18
07640125650488Press ModularPress Modular70402016-09-18
07640125650495Traceability Labels for cryopreservationTraceability Labels for cryopreservation70112016-09-18
07640125650501Traceability Labels for BioarchiveTraceability Labels for Bioarchive70312016-09-18
07640125650556Insertion ToolInsertion Tool70302016-09-18
07640125650075Regenerative medicine-Single-use kitsCS-470.0100342016-09-18
07640125650099Sepax single-use kitCS-470.1100052016-09-18
07640125650259Stem Cell Banking-Single-use kitsCS-570.4100302017-01-13
07640125650341Double Spike AccessoryFA-200.1100432017-01-13
07640125650365CryoSC-S Freezing BagFB-100.1100232017-01-13
07640125650389CryoSC-D Freezing BagFB-100.2100322017-01-13
07640125650402CryoSC-Db Freezing BagFB-100.2b100412017-01-13
07640125650273Stem Cell Banking-Single-use kitsCS-570.4mb100392016-09-18
07640125650563CryoSC-D Seal positionerCryoSC-D Seal positioner70262016-09-18
07640125650532Metal Storage CanisterMetal Storage Canister70122016-09-18
07640125650570CryoSC-Db Seal positionerCryoSC-Db Seal positioner70352016-09-18
07640125650457Separation Chamber HolderSeparation Chamber Holder60332016-09-18
07640125650464DMSO Vial Adaptator 7 mlDMSO Vial Adaptator 7 ml60762016-09-18

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