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Thermo Scientific

Primary DI
10850685007002
Brand
Thermo Scientific
Company
Thermo Electron LED GmbH
Model
CW3 Cell Washer
Catalog number
75007504
Published
2017-03-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSNCentrifuge, Cell-Washing, Automated For Immuno-HematologyHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK1600440

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1600440

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850685007002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085068500700210850685007002

GMDN Terms#

Term, Definition table
TermDefinition
Cell washer IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to separate red blood cells from whole blood and wash the intact red blood cells, typically through low-speed centrifugal force, to remove plasma, debris and/or any other extraneous material so they are free from interfering substances and suitable for use in subsequent in vitro clinical testing (e.g., antiglobulin). The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
537396330
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850044310262Thermo ScientificThermo Scientific MT 17 IVD-MD750025772026-05-21
10850044310279Thermo ScientificThermo Scientific MT 17 IVD-MD750025782026-05-21
10850044310309Thermo ScientificThermo Scientific MT 21 IVD-MD750025802026-05-21
10850044310323Fisher ScientificFisherbrand accuSpin 17-HC750025282026-04-22
10850044310347Fisher ScientificFisherbrand accuSpin 17R-HC750025292026-04-22
10850044310354Fisher ScientificFisherbrand accuSpin 21-HC750025302026-04-22
10850044310422Fisher ScientificFisherbrand accuSpin 21R-HC750025312026-04-22
10850044310224Thermo ScientificThermo Scientific S4T IVD-MD750073322026-04-02
10850044310248Thermo ScientificThermo Scientific X4T IVD-MD750073412026-04-02
10850044310255Thermo ScientificThermo Scientific MT 17 IVD-MD750025762026-03-10
10850044310286Thermo ScientificThermo Scientific MT 17 IVD-MD750025982026-03-10
10850044310293Thermo ScientificThermo Scientific MT 21 IVD-MD750025792026-03-10
10850044310378Thermo ScientificThermo Scientific MTR 17 IVD-MD750025882026-03-10
10850044310392Thermo ScientificThermo Scientific MTR 21 IVD-MD750025912026-03-10
10850044310484Thermo ScientificThermo Scientific MTR 21 IVD-MD750025992026-03-10
10850044310491Thermo ScientificThermo Scientific MTR 17 IVD-MD750025972026-03-10
10850044310033Thermo ScientificThermo Scientific C1TR IVD-MD750091022025-12-01
10850044310149Thermo ScientificThermo Scientific C1FR IVD-MD750091202025-12-01
10850044310170Thermo ScientificThermo Scientific C1T IVD-MD750080042025-12-01
10850044310187Thermo ScientificThermo Scientific C1T IVD-MD750080052025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394020933UltraCW®II HELMER, INC.KSN2018-04-13
10816934020772Thermo Scientific Sorvall Blood Washing SystemKEY SCIENTIFIC INCKSN2016-09-23
10816934020789Thermo Scientific Sorvall Blood Cell Washing SystemKEY SCIENTIFIC INCKSN2016-09-23
10758750005802MTSMICRO TYPING SYSTEMS, INCKSN2016-08-24
10758750030149ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.KSN2016-08-24
00816394020902UltraCW® HELMER, INC.KSN2016-07-01