FDA.reportPublic FDA data

VERIFY

Primary DI
00724995002541
Brand
VERIFY
Company
STERIS CORPORATION
Model
LCB030
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
2019-04-01
Public version status
Update
Distribution status
Not 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
00724995153052PreviousGS10
00724995201838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995002541007249950025417249950025410724995002541
00724995153052007249951530527249951530520724995153052
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.

Sterilization Methods#

Method table
Method

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
00724995234232V. MuellerCD14BCD14B2026-08-26
00724995234249V. MuellerCD14BBLACKCD14BBLACK2026-08-26
00724995234256V. MuellerCD14BBLUECD14BBLUE2026-08-26
00724995234263V. MuellerCD14BGOLDCD14BGOLD2026-08-26
00724995234270V. MuellerCD14BGREENCD14BGREEN2026-08-26
00724995234287V. MuellerCD14BPURPLECD14BPURPLE2026-08-26
00724995234294V. MuellerCD14BREDCD14BRED2026-08-26
00724995234300V. MuellerCD14CCD14C2026-08-26
00724995234317V. MuellerCD14CBLACKCD14CBLACK2026-08-26
00724995234324V. MuellerCD14CBLUECD14CBLUE2026-08-26
00724995234331V. MuellerCD14CGOLDCD14CGOLD2026-08-26
00724995234348V. MuellerCD14CGREENCD14CGREEN2026-08-26
00724995234355V. MuellerCD14CPURPLECD14CPURPLE2026-08-26
00724995234362V. MuellerCD14CREDCD14CRED2026-08-26
00724995234379V. MuellerCD15BCD15B2026-08-26
00724995234386V. MuellerCD15BBLACKCD15BBLACK2026-08-26
00724995234393V. MuellerCD15BBLUECD15BBLUE2026-08-26
00724995234409V. MuellerCD15BGOLDCD15BGOLD2026-08-26
00724995234416V. MuellerCD15BGREENCD15BGREEN2026-08-26
00724995234423V. MuellerCD15BPURPLECD15BPURPLE2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995201838VERIFYSTERIS CORPORATIONOWP2022-04-25
10724995153028VERIFY AssertSTERIS CORPORATIONOWP2017-07-27
10724995153035VERIFY AssertSTERIS CORPORATIONOWP2017-07-27
00724995153052VERIFYSTERIS CORPORATIONOWP2017-07-27
10724995153011VERIFY AssertSTERIS CORPORATIONOWP2017-07-01