AccessGUDID - DEVICE: VERIFY (10724995095557)

GUDID

Device Identifier (DI) Information

Brand Name: VERIFY
Version or Model: PCC039
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCC039
Company Name: STERIS CORPORATION

Primary DI Number: 10724995095557
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2020
Device Count: 250
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The VERIFY Chemical Integrating Indicators monitor all critical parameters of steam sterilization (time, temperature and steam quality).

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 [?]
K895910	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
Special Storage Condition, Specify: Keep away from direct light
Storage Environment Humidity: between 35 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: less than 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00266814-831f-42a5-8d57-42675b598ab4
Public Version Date: February 21, 2025
Public Version Number: 8
DI Record Publish Date: September 09, 2016