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
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
10885403015960V. MuellerBP0-1ABP01A2017-11-17
10885403015977V. MuellerBP0-2ABP02A2017-11-17
10885403015991V. MuellerBP0-2VBP02V2017-11-17
10885403016004V. MuellerBP1-1ASBP11AS2017-11-17
10885403016011V. MuellerBP1-2ABP12A2017-11-17
10885403016035V. MuellerBP1-2ASBP12AS2017-11-17
10885403016066V. MuellerBP1-2VBP12V2017-11-17
10885403016073V. MuellerBP1-2VSBP12VS2017-11-17
10885403016080V. MuellerBP1-3ABP13A2017-11-17
10885403016103V. MuellerBP1-3VBP13V2017-11-17

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