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
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
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