UltraCW®II

Basic Information

• Brand Name: UltraCW®II
• Primary DI: 00816394020933
• Version / Model: UltraCW II
• Catalog Number: N/A
• Company Name: HELMER, INC.
• Labeler DUNS: 086685682
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-13
• Public Version: 1
• Public Version Date: 2018-05-14
• Public Version Status: New
• Public Device Record Key: 69efa694-e2f2-4305-b541-c6d1f248c9a0

Device Description

Automated Cell Washing System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSN	Centrifuge, Cell-Washing, Automated For Immuno-Hematology	Hematology	864.9285	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35901	Cell washer IVD	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816394020933	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]