FDA.report

Medline

Primary DI
20080196756992
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS200150C
Catalog number
MDS200150C
Device description
STRIP,STEAM INDICATOR,8",9BX/CS
Published
2020-12-31
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
20080196756992PackageGS1250In Commercial Distribution
30080196756999PackageGS1250In Commercial Distribution
40080196756996PackageGS12250In Commercial Distribution
10080196756995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2008019675699220080196756992
3008019675699930080196756999
4008019675699640080196756996
1008019675699510080196756995

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
1
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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20080196286789MEDLINEMDT2168282MDT21682822016-10-14
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20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
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H816PIT3401ProChek IDCERTOL INTERNATIONAL, LLCLRT2017-01-13
H816PIT1002ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
H816PIT1201ProChek IDCERTOL INTERNATIONAL, LLCLRT2016-09-23
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