DxH 500 Series Cleaner

Basic Information

• Brand Name: DxH 500 Series Cleaner
• Primary DI: 15099590671877
• Version / Model: B36868
• Catalog Number: B36868
• Company Name: BECKMAN COULTER IRELAND INC.
• Labeler DUNS: 985071975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: 8c637df2-6bc8-491a-9d72-3c1fb0d6d0c1

Device Description

DxH 500 Series Cleaner

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JCB	Detergent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590671877	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius