AccessGUDID - DEVICE: VERIFY (10724995087941)

GUDID

Device Identifier (DI) Information

Brand Name: VERIFY
Version or Model: PCC029
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCC029
Company Name: ALBERT BROWNE LIMITED

Primary DI Number: 10724995087941
Issuing Agency: GS1
Commercial Distribution End Date: May 22, 2020
Device Count: 60
Labeler D-U-N-S® Number*: 218172765 *Terms of Use

Device Description: The VERIFY Process Indicator for the Reliance EPS Endoscope Processing System is a peracetic acid concentration indicator that changes color to the ENDPOINT reference block upon exposure to an effective dose of peracetic acid. It is intended for use for routine monitoring of the Reliance EPS Endoscope Processing System employing Reliance DG Dry Germicide.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K063285	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
Special Storage Condition, Specify: Keep Dry and Keep away from direct light
Storage Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 43 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e837aabd-a138-4cc7-9f8a-f039ea354801
Public Version Date: February 21, 2025
Public Version Number: 8
DI Record Publish Date: September 06, 2016