Identifiers
- 510(k) Number
- K053479 FDA 510(k)
- FDA Product Code
- JOJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.2800 FDA 510(k)
- Regulation Number
- 880.2800 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Verify Dry Heat Label is a Physical/Chemical Sterilization Process Indicator designed to verify the completion of dry heat sterilization cycles. It visually confirms whether packaged goods have undergone the required sterilization process by changing color when exposed to the appropriate temperature and time parameters, ensuring process validation in medical and general hospital settings.
This single-use indicator is applied to packaged items prior to dry heat sterilization and is regulated under FDA 510(k) clearance (K053479) as a Class 2 device. It adheres to ANSI/AAMI ST60 standards for Class I process indicators and is supplied as a non-sterile label, intended for use in controlled environments such as sterilization facilities. The device is not MRI-safe and must be stored in a dry, protected environment to maintain integrity before use.
Frequently asked questions
What is the Verify Dry Heat Label used for?
The Verify Dry Heat Label is a physical/chemical sterilization process indicator designed to confirm that packaged items have undergone the correct dry heat sterilization cycle. It changes color when exposed to the required temperature and time, providing visual proof that the sterilization process was completed successfully. This helps validate the sterilization process in medical and general hospital settings.
How is the Verify Dry Heat Label supplied and what is its sterility status?
The Verify Dry Heat Label is supplied as a non-sterile label. It is intended for use in controlled environments like sterilization facilities and is not pre-sterilized. The label itself must be applied to items prior to sterilization, ensuring it is exposed to the dry heat process alongside the packaged goods.
Is the Verify Dry Heat Label single-use or reusable?
The Verify Dry Heat Label is designed for single-use only. After it changes color to confirm sterilization, it should be discarded. Reusing the label could compromise its accuracy and reliability, as it is intended to provide a one-time visual confirmation of the sterilization process.
How should the Verify Dry Heat Label be stored before use?
The Verify Dry Heat Label must be stored in a dry, protected environment to maintain its integrity before use. Exposure to moisture or environmental contaminants could affect its performance, so it should be kept in a sealed package until ready for application to items intended for sterilization.
What regulatory standards does the Verify Dry Heat Label comply with?
The Verify Dry Heat Label adheres to ANSI/AAMI ST60 standards for Class I process indicators. It is also regulated under FDA 510(k) clearance (K053479) as a Class 2 device, ensuring it meets specific safety and performance requirements for use in medical and hospital sterilization processes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K053479 FDA 510 (k) - VERIFY DRY HEAT LABEL, VERIFY DRY HEAT LABEL (K053479) — FDA 510(k) | Innolitics, PDF Verify' Dry Heat Label - Food and Drug Administration, Albert Browne , Ltd. FDA 510 (k) Products (1997-2007)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053479 | Class II | Active |
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Manufacturer
- Manufacturer
- Albert Browne , Ltd.
Sources (1)
- FDA 510(k) K053479 24 fields · synced Oct 1, 2026