AccessGUDID - DEVICE: Renu-Klenz (00724995041878)

GUDID

Device Identifier (DI) Information

Brand Name: Renu-Klenz
Version or Model: 1777BX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1777BX
Company Name: STERIS CORPORATION

Primary DI Number: 00724995041878
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 139424188 *Terms of Use

Device Description: Renu-Klenz Neutral pH Cleaner 1 Gallon Bag,is effective in removing blood, soil and other common stains and is appropriate for ultrasonic machines, automated washing equipment and manual cleaning applications.

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?
63385	Medical device cleaning agent	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, ultrasonic, medical instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 75576033-2eee-40e8-a359-55d4cf9fdf8c
Public Version Date: April 08, 2021
Public Version Number: 1
DI Record Publish Date: March 31, 2021