AccessGUDID - DEVICE: VERIFY (10724995001848)

GUDID

Device Identifier (DI) Information

Brand Name: VERIFY
Version or Model: PCC061
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCC061
Company Name: ALBERT BROWNE LIMITED

Primary DI Number: 10724995001848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 218172765 *Terms of Use

Device Description: The VERIFY HPU Chemical Indicator is a vaporized hydrogen peroxide sterilization process indicator designed for use in the V-PRO Low Temperature Sterilization Systems.

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 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 [?]
K140515	000
K172746	000
K231488	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: f5cfdd78-043b-4845-b921-fe944ee8358a
Public Version Date: February 27, 2024
Public Version Number: 11
DI Record Publish Date: September 06, 2016