FDA.report

Medline

Primary DI
10080196729586
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS200100
Catalog number
MDS200100
Device description
STRIP,STEAM INDICATOR,4"
Published
2021-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LRTINDICATOR, STERILIZATION

Product Code Classifications

CodeDeviceSpecialtyClass
LRTIndicator, SterilizationGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30080196729580PrimaryGS10
10080196729586Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3008019672958030080196729580
1008019672958610080196729586

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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

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30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
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40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

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40080196479000MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.LRT2022-03-23
30080196756982MedlineMEDLINE INDUSTRIES, INC.LRT2021-01-02
20080196756992MedlineMEDLINE INDUSTRIES, INC.LRT2020-12-31
10818087013410Propper 1" Gas-Chex Sterilization TapePROPPER MANUFACTURING COMPANY, INC.LRT2020-03-04
20814434021197Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
20814434021203Getinge Assured Steam Sterilization IndicatorSTERITEC PRODUCT MFG. CO., INC.LRT2019-06-10
70818087011920Propper Gas-Chex EO Gas 3/4" Indicator TapePROPPER MANUFACTURING COMPANY, INC.LRT2018-09-26
30818087011960Propper Gas-Chex Indicator StripsPROPPER MANUFACTURING COMPANY, INC.LRT2017-10-04
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
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
30809160002524Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LRT2016-08-20
17540196000625Sterilization Monitors, SteamScican LtdLRT2016-08-02