FDA.reportPublic FDA data

Medline

Primary DI
10884389579985
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDINSERTKIT
Catalog number
DYNDINSERTKIT
Device description
INTERMITTENT CATH INSERTION KT
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389579986PackageGS1100In Commercial Distribution
10884389579985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438957998640884389579986
1088438957998510884389579985

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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
10198459678653MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678660MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678677MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678684MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678691MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459679025MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
00850067913023TruCath®HR PHARMACEUTICALS INC.OHR2026-07-23
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
00610075096541VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096602VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096619VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096626VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096633VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075095667VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095674VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095681VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095698VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095704VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13