FDA.reportPublic FDA data

UltraCW®

Primary DI
00816394020902
Brand
UltraCW®
Company
HELMER, INC.
Model
UltraCW
Device description
Automatic Cell Washing System
Published
2016-07-01
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
KSNCentrifuge, Cell-Washing, Automated For Immuno-Hematology

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816394020902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816394020902008163940209028163940209020816394020902

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

Contacts#

Phone, Email table
PhoneEmail
317-773-9073techservice@helmerinc.com

Regulatory Flags#

DUNS number
086685682
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816394021855Helmer ScientificHPR118-GXC2026-05-13
00816394021916Helmer ScientificHBR118-GXC2026-05-13
00816394021923Helmer ScientificiBR118-GXC2026-05-13
00816394021930Helmer ScientificHLR118-GXC2026-05-13
00816394021947Helmer ScientificiLR118-GXC2026-05-13
00816394021954Helmer ScientificiPR118-GXC2026-05-13
00816394021961Helmer ScientificHBR120-GXC2026-05-13
00816394021978Helmer ScientificiBR120-GXC2026-05-13
00816394021985Helmer ScientificHLR120-GXC2026-05-13
00816394021992Helmer ScientificiLR120-GXC2026-05-13
00816394022005Helmer ScientificHPR120-GXC2026-05-13
00816394022012Helmer ScientificiPR120-GXC2026-05-13
00816394022036Helmer ScientificHBR125-GXC2026-05-13
00816394022043Helmer ScientificiBR125-GXC2026-05-13
00816394022050Helmer ScientificHLR125-GXC2026-05-13
00816394022067Helmer ScientificiLR125-GXC2026-05-13
00816394022074Helmer ScientificHPR125-GXC2026-05-13
00816394022081Helmer ScientificiPR125-GXC2026-05-13
00816394021824FarrarFCF1332025-01-10
00816394021640HelmeriUF126-GX2019-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394020933UltraCW®II HELMER, INC.KSN2018-04-13
10850685007002Thermo ScientificThermo Electron LED GmbHKSN2017-03-24
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