FDA.reportPublic FDA data

VERIFY

Primary DI
00724995090036
Brand
VERIFY
Company
STERIS CORPORATION
Model
LCB004
Catalog number
LCB004
Device description
The VERIFY Self-Contained Biological Indicator HP Activator is used to seal and activate VERIFY Biological Indicators.
Published
2016-09-09
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
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
K140708000

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
K140708000VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATORSTERIS Corporation2014-06-16FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995090036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995090036007249950900367249950900360724995090036

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.

Contacts#

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

Regulatory Flags#

DUNS number
961394798
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
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