FDA.reportPublic FDA data

VERIFY

Primary DI
00724995162771
Brand
VERIFY
Company
STERIS CORPORATION
Model
LCB055
Catalog number
LCB055
Device description
The VERIFY All-In-One Steam Reusable Test Pack is designed to challenge vacuum assisted steam sterilizers operating at 270 degrees farenheit for a 4-minute exposure and can be used 200 times.
Published
2019-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, biological sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092944000
K102761000
K103321000
K110253000
K120592000
K130135000
K133267000
K173633000
K182931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092944000DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONDana Products, Inc.2010-03-18FRC
K102761000DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONDana Products, Inc.2010-12-20JOJ
K103321000DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLESDana Products, Inc.2011-02-16FRC
K110253000REUSABLE TEST PACK FOR DANA EMULATING INDICATORSDana Products, Inc.2011-04-29JOJ
K120592000DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORSDana Products, Inc.2013-02-27JOJ
K130135000DANA REUSABLE BI TEST PACKDana Products, Inc.2013-11-25JOJ
K133267000DANA REUSABLE TEST PACKDana Products, Inc.2014-02-11FRC
K173633000VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker TagSTERIS Corporation2018-02-28FRC
K182931000VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker TagSteris Corporations2018-11-20FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995162771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995162771007249951627717249951627710724995162771

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
040469731
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403107030V. MuellerR1134R11342016-09-23
10885403133824V. MuellerTB1-1TB112018-03-19
10885403133831V. MuellerTB1-2TB122018-03-19
10885403133848V. MuellerTB1-5TB152018-03-19
10885403133855V. MuellerTB1-6TB162018-03-19
10885403133862V. MuellerTC2-2TC222016-09-24
10885403179020V. MuellerR1142R11422016-09-23
10885403179037V. MuellerR1623R16232018-03-19
10885403179129V. MuellerR1589R15892016-09-23
10885403179136V. MuellerR1590R15902016-09-23
10885403185311V. MuellerTB1-10TB1102018-03-19
10885403185328V. MuellerTB1-12TB1122018-03-19
10885403185335V. MuellerTB1-3TB132018-03-19
10885403185342V. MuellerTB1-4TB142018-03-19
10885403185359V. MuellerTB1-7TB172018-03-19
10885403185366V. MuellerTB2-1TB212018-03-19
10885403185373V. MuellerTB2-10TB2102018-03-19
10885403185380V. MuellerTB2-12TB2122018-03-19
10885403185397V. MuellerTB2-2TB222018-03-19
10885403185403V. MuellerTB2-3TB232018-03-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
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M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772983BIOTRACE™TERRAGENE S.A.FRC2024-11-12
10686864060892Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14