FDA.reportPublic FDA data

VERIFY

Primary DI
10724995180291
Brand
VERIFY
Company
STERIS CORPORATION
Model
LCB005
Catalog number
LCB005
Device description
The VERIFY V24 Challenge Pack is for qualifications testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
Published
2021-04-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, biological sterilization process
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073618000
K090514000
K092906000
K103331000
K140499000
K172748000
K183300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073618000VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACKSTERIS Corporation2009-01-07FRC
K090514000VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSESSTERIS Corporation2009-03-16FRC
K092906000VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATIONSTERIS Corporation2009-12-30FRC
K103331000VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSESSTERIS Corporation2011-09-01JOJ
K140499000VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSESSTERIS Corporation2014-07-17FRC
K172748000VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations2018-02-09FRC
K183300000VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge PackSteris Corporations2019-01-03FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995084674PreviousGS10
10724995180291PrimaryGS10
00724995180294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499508467410724995084674
1072499518029110724995180291
00724995180294007249951802947249951802940724995180294

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct light
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature70 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
961394798
Device count
5
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995239909V. MuellerDP11DP112026-10-15
00724995239916V. MuellerDP12DP122026-10-15
00724995239923V. MuellerDP13DP132026-10-15
00724995239930V. MuellerDP14DP142026-10-15
00724995239947V. MuellerDP15DP152026-10-15
00724995239985V. MuellerED112ED1122026-10-15
00724995239992V. MuellerED15ED152026-10-15
00724995240004V. MuellerED16ED162026-10-15
00724995240011V. MuellerED17ED172026-10-15
00724995240028V. MuellerED19ED192026-10-15
00724995240660V. MuellerPP11PP112026-10-15
00724995240677V. MuellerPP12PP122026-10-15
00724995240684V. MuellerPP125PP1252026-10-15
00724995240691V. MuellerPP13PP132026-10-15
00724995240707V. MuellerPP14PP142026-10-15
00724995241025V. MuellerR1051R10512026-10-15
00724995241049V. MuellerR1065R10652026-10-15
00724995241056V. MuellerR1067R10672026-10-15
00724995241063V. MuellerR1069R10692026-10-15
00724995241070V. MuellerR1072R10722026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995362973VERIFYALBERT BROWNE LIMITEDJOJ2026-07-16
30818087011618Propper Vapor Line IntegratorsPROPPER MANUFACTURING COMPANY, INC.JOJ2026-07-16
00840456206881JMUJMU DENTAL, INCJOJ2026-07-08
00840456206898JMUJMU DENTAL, INCJOJ2026-07-08
00840456206928JMUJMU DENTAL, INCJOJ2026-07-08
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCJOJ2026-06-05
00840456201930JMUJMU DENTAL, INCJOJ2026-06-05
00840456201947JMUJMU DENTAL, INCJOJ2026-06-05
00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
00840456202975JMUJMU DENTAL, INCJOJ2026-06-05
00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05