FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380112147
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
T40302
Catalog number
T40302
Device description
Indicator, Steam 4 in.
Published
2016-09-23
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
LRTINDICATOR, STERILIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRTIndicator, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380112148PackageGS124Not in Commercial Distribution
20885380112147PrimaryGS10
10885380112140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538011214850885380112148
2088538011214720885380112147
1088538011214010885380112140

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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818087010952"Gas-Chex EO Gas 3/4"" Indicator Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2023-06-16
H816MSM43401ProCheck IDMicroCare, LLCLRT2022-10-26
H816MSM43402ProCheck IDMicroCare, LLCLRT2022-10-26
10080196479009MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.LRT2022-03-23
40080196479000MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.LRT2022-03-23
30080196729580MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-26
10080196729586MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-26
10080196756988MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-02
30080196756982MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-02
10080196756995MedlineMEDLINE INDUSTRIES, INC.LRT2020-12-31
20080196756992MedlineMEDLINE INDUSTRIES, INC.LRT2020-12-31
70818087013412"Propper 1"" Gas-Chex Sterilization Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2020-03-04
10818087013410Propper 1" Gas-Chex Sterilization TapePROPPER MANUFACTURING COMPANY, INC.LRT2020-03-04
00814434021193Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
00814434021209Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
20814434021197Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
20814434021203Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
70818087011920"Propper Gas-Chex EO Gas 3/4"" Indicator Tape"PROPPER MANUFACTURING COMPANY, INC.LRT2018-09-26
30818087011977Propper Gas-Chex Indicator StripsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
30818087012936Propper Steri-Dot IndicatorsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
30818087012943Propper Steri-Dot IndicatorsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
H816PIT3401ProChek IDCERTOL INTERNATIONAL, LLCLRT2017-01-13
H816PIT1001ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816SM43401ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
20885380112529CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23
H816PIT1002ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816PIT1201ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816SM43402ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
50885380112148CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23
50885380112520CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23