AccessGUDID - DEVICE: Reliance (00724995193690)

GUDID

Device Identifier (DI) Information

Brand Name: Reliance
Version or Model: EPS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MB000080
Company Name: Corporation Steris Canada

Primary DI Number: 00724995193690
Issuing Agency: GS1
Commercial Distribution End Date: October 28, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 202659140 *Terms of Use

Device Description: The Reliance EPS Processor with base is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.

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:	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35012	Endoscope washer/disinfector	A mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes, and their accessories, with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 79a698d6-a24b-4b3d-924b-80f046c30c52
Public Version Date: October 31, 2022
Public Version Number: 4
DI Record Publish Date: September 04, 2020