FDA.reportPublic FDA data

VERIFY

Primary DI
00724995201838
Brand
VERIFY
Company
STERIS CORPORATION
Model
Incubator
Catalog number
LCB030
Device description
The VERIFY Incubator is for exclusive use with VERIFY Assert Self-Contained Biological Indicators and VERIFY Process Challenge Devices.
Published
2022-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OWPBiological sterilization process indicator with recombinant-dna plasmid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWPBiological Sterilization Process Indicator With Recombinant-Dna PlasmidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163587000VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation2017-03-24OWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995002541PreviousGS10
00724995201838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995002541007249950025417249950025410724995002541
00724995201838007249952018387249952018380724995201838

GMDN Terms#

Term, Definition table
TermDefinition
Test tube heaterAn electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.

Contacts#

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

Regulatory Flags#

DUNS number
868205779
Device count
1
Serial number
true
Manufacturing 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
00724995002541VERIFYSTERIS CORPORATIONOWP2019-04-01
10724995153028VERIFY AssertSTERIS CORPORATIONOWP2017-07-27
10724995153035VERIFY AssertSTERIS CORPORATIONOWP2017-07-27
00724995153052VERIFYSTERIS CORPORATIONOWP2017-07-27
10724995153011VERIFY AssertSTERIS CORPORATIONOWP2017-07-01