FDA.reportPublic FDA data

MEDLINE

Primary DI
20193489008576
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYK500TS
Catalog number
DYK500TS
Device description
BEDSIDE KIT, 500ML, TUBULAR SPONGE
Published
2025-07-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNLACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489008576PackageGS125In Commercial Distribution
10193489008579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348900857620193489008576
1019348900857910193489008579

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning sponge/setA hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926044PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926051PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926341PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926471PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926686PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926761PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826927232PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928369PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928376PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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00810929045675Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
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10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045696Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045702Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07