FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380112148
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
50885380112148PackageGS124In 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 respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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
20885380112147CARDINAL HEALTHCardinal Health 200, 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
50885380112520CARDINAL HEALTHCardinal Health 200, LLCLRT2016-09-23