FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380112093
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
T40366
Catalog number
T40366
Device description
Emulator, Class 6, Steam
Published
2016-10-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380112094PackageGS116Not in Commercial Distribution
20885380112093PrimaryGS10
10885380112096Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538011209450885380112094
2088538011209320885380112093
1088538011209610885380112096

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
250
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D771603531Dental CityICP, INC.JOJ2026-05-27
D771604231Dental CityICP, INC.JOJ2026-05-27
D771604251Dental CityICP, INC.JOJ2026-05-27
D771604271Dental CityICP, INC.JOJ2026-05-27
D771604281Dental CityICP, INC.JOJ2026-05-27
D771604291Dental CityICP, INC.JOJ2026-05-27
D771604391Dental CityICP, INC.JOJ2026-05-27
107073877931703M™ Attest™3M COMPANYJOJ2026-04-26
10705037015979Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-18
10705037015924Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015948Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015955Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015962Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015917Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
10686864061233AssureCheck™TERRAGENE S.A.JOJ2025-10-16
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10724995245525Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
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07798375772853SEALSURE™TERRAGENE S.A.JOJ2025-06-03
10615375013516MetriCide METREX RESEARCH, LLCJOJ2025-03-21
10686864061165Medicom SafeSealAMD Medicom IncJOJ2025-03-20
07798375772730VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772747VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772792VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772624BIOTRACE™TERRAGENE S.A.JOJ2024-11-12
07798375772839VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772952VERISURE™TERRAGENE S.A.JOJ2024-11-12
10724995229549CelerityALBERT BROWNE LIMITEDJOJ2024-04-22
10724995229495VERIFYALBERT BROWNE LIMITEDJOJ2024-04-08