Reliance

Basic Information

• Brand Name: Reliance
• Primary DI: 10724995083776
• Version / Model: D5100
• Catalog Number: D5100
• Company Name: STERIS CORPORATION
• Labeler DUNS: 828222781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 14
• Public Version Date: 2023-07-04
• Public Version Status: Update
• Public Device Record Key: 46f3e0c1-5749-4e15-bfdd-a3c7335a9b9e

Device Description

The Reliance DG Dry Germicide is a single-use dry germicide used only in the Reliance EPS Endoscope Processing System. The net contents are 272g per cup.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
NZA	Accessories, germicide, cleaning, for endoscopes	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47631	Medical device disinfection agent	A non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50724995083774	GS1	Case	4	In Commercial Distribution
Primary	10724995083776	GS1
Unit of Use	00724995083779	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K040049	000
K102244	000
K200989	000
K203223	000
K220361	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 16 – 27 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep upright, dry, and in a clean environment. Avoid extreme heat and humidity