AccessGUDID - DEVICE: Reliance (10724995083776)

GUDID

Device Identifier (DI) Information

Brand Name: Reliance
Version or Model: D5100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: D5100
Company Name: STERIS CORPORATION

Primary DI Number: 10724995083776
Issuing Agency: GS1
Commercial Distribution End Date: April 29, 2025
Device Count: 5
Labeler D-U-N-S® Number*: 828222781 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZA	Accessories, germicide, cleaning, for endoscopes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040049	000
K102244	000
K200989	000
K203223	000
K220361	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46f3e0c1-5749-4e15-bfdd-a3c7335a9b9e
Public Version Date: April 30, 2025
Public Version Number: 15
DI Record Publish Date: September 08, 2016