FDA.report

MEDLINE

Primary DI
20193489189541
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
MSC351320
Catalog number
MSC351320
Device description
WIPE,MICRO-KILL ONE,7X8,FLAT PACK
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LRJDisinfectant, medical devices

Product Code Classifications

CodeDeviceSpecialtyClass
LRJDisinfectant, Medical DevicesGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489189541PackageGS112In Commercial Distribution
10193489189544PrimaryGS10
80193489189543Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348918954120193489189541
1019348918954410193489189544
8019348918954380193489189543

GMDN Terms

TermDefinition
Medical device cleaning/disinfection wipeA moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
60
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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