VERIFY LCB030

GUDID 00724995002541

The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicators and VERIFY Process Challenge Devices.

STERIS CORPORATION

Test tube heater

• Primary Device ID: 00724995002541
• NIH Device Record Key: c41ebcdb-363d-4b2d-b662-06e336f2d002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERIFY
• Version Model Number: Incubator
• Catalog Number: LCB030
• Company DUNS: 868205779
• Company Name: STERIS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995002541 [Previous]
GS1	00724995201838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163587

FDA Product Code

• OWP: Biological sterilization process indicator with recombinant-dna plasmid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [VERIFY]

• 00724995153052: The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicator
• 00724995090036: The VERIFY Self-Contained Biological Indicator HP Activator is used to seal and activate VERIFY
• 00724995023904: The VERIFY Vial Activator Set is used with the VERIFY Biological EO Test Pack.
• 00724995002602: All-In-One STEAM Reusable Test Pack with Tag. Kit includes 2 test packs with tags, 200 VERIFY ST
• 00724995002596: All-In-One STEAM Reusable Test Pack with Step Counter. Kit includes 2 test packs with step count
• 00724995002589: All-In-One STEAM Reusable Test Pack. Kit includes 2 test packs, 200 VERIFY STEAM Integrating Ind
• 00724995002572: The VERIFY All-In-One STEAM Reusable Test Pack with Tag includes 1 test pack with tag and 200 VE
• 00724995002565: The VERIFY All-In-One STEAM Reusable Test Pack with Step Counter includes 1 test pack with Step
• 00724995002558: The VERIFY All-In-One STEAM Reusable Test Pack includes 1 test pack and 200 VERIFY STEAM Integra
• 00724995002534: The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials
• 50724995153217: The VERIFY All-In-One PV10 Assembly is a single-use plastic tube that is designed to hold a biol
• 00724995162795: The VERIFY All-In-One Steam Reusable Test Pack with Tracker Tag is designed to challenge vacuum
• 00724995162788: The VERIFY All-In-One Steam Reusable Test Pack with Step Counter is designed to challenge vacuum
• 00724995162771: The VERIFY All-In-One Steam Reusable Test Pack is designed to challenge vacuum assisted steam st
• 10724995021464: The VERIFY Dual Integrators monitor all critical parameters of steam (temperature, time and stea
• 10724995021471: The VERIFY Dual Integrators monitor all critical parameters of steam (temperature, time and stea
• 10724995172593: The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials
• 10724995095557: The VERIFY Chemical Integrating Indicators monitor all critical parameters of steam sterilizatio
• 10724995023888: The VERIFY Dual Species Self-Contained Biological Indicators are for use in monitoring healthcar
• 10724995023871: The VERIFY Disposable Biological EO Test Packs are for use in monitoring healthcare ethylene oxi
• 50724995153224: The VERIFY Steam Integrating Indicator 5CM is designed to verify, following a sterilization proc
• 10724995002388: The VERIFY All-in-One Bowie Dick Indicator Strips is for exclusive use with the VERIFY All-In-On
• 50724995002102: The VERIFY Steam Integrating Indicator 5CM strip is for use in a variety of cycles and incorpora
• 50724995002096: The VERIFY Steam Integrating Indicator four-inch strip is for use in a variety of cycles and inc
• 10724995021426: The VERIFY Laminated Steam and EO Integrator Strips are designed to monitor all critical paramet
• 10724995096240: The VERIFY Spore Test Strip for S40 Sterilant offers the ability to test sporicidal activity of
• 10724995090866: The VERIFY V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lum
• 10724995085671: The VERIFY Biological Integrator Challenge Packs are used to release dynamic air removal (prevac
• 10724995084674: The VERIFY V24 Challenge Pack is for qualifications testing of the V-PRO Low Temperature Sterili
• 10724995084667: The VERIFY Biological Integrator Challenge Packs are used to release dynamic air removal (prevac
• 50724995084573: The VERIFY Bowie Dick Test Pack Air Removal is designed to monitor air removal and steam penetra
• 10724995024007: The VERIFY Bowie Dick Test Card is a pre-assembled Bowie-Dick test pack product. The Card is the
• 10724995023864: The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitori
• 10724995023840: The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitori
• 50724995023824: The VERIFY Dual Species Self-Contained Biological Indicator is for use in installation testing a
• 10724995021396: The VERIFY Steam Sterilizer Load Record Cards, document load contents and confirm the load has b
• 10724995021389: The VERIFY Flash Integrator and Patient Record is used for monitoring flash sterilization cycles
• 10724995021358: The VERIFY Integrator Steam Integrator Strips monitor all critical parameters of steam steriliza
• 10724995021341: The VERIFY Integrator Steam Integrator Strips monitor all critical parameters of steam steriliza
• 10724995002524: The VERIFY Steam Integrating Indicator four-inch strip is for use in a variety of cycles and is
• 50724995002324: Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Medium is designed to detect a broad s
• 50724995002317: Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small is designed to detect a broad sp
• 50724995002300: Brush for VERIFY RESI-TEST Endo Protein Detection Cleaning Indicator, Large is designed to detec
• 50724995002171: VERIFY RESI-TEST Swab Cleaning Indicator is designed to detect a broad spectrum of protein resid
• 00724995095659: VERIFY 6 Well Incubator, 55-60 Degree Celsius, are specially designed for use with VERIFY Biolog
• 00724995023935: VERIFY 28 well and 6 well 55-60 Degree Celsius Incubator fits individual facility incubation nee
• 00724995023928: VERIFY Large Dual Incubator is specially designed for use with VERIFY Biological Indicators.
• 00724995023911: VERIFY Dual Temperature 28 well incubator allows incubation at two different temperatures in one
• 00724995002541: The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicator
• 10724995216563: Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small is designed to detect a broad sp