FDA.reportPublic FDA data

Medline

Primary DI
40888277866646
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
URO170814
Catalog number
URO170814
Device description
14FR 10ML 100% SILI FOLEY UM TOTAL TRAY
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
40888277866646PackageGS110In Commercial Distribution
10888277866645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827786664640888277866646
1088827786664510888277866645

GMDN Terms#

Term, Definition table
TermDefinition
Catheter care kitA collection of sterile devices designed to clean or otherwise maintain catheter patency. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Label does not mention Storage Conditions

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
true
Premarket exempt
true
HCT/P
false
Kit
true
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
10080196320417MEDLINEMDS30102MDS301022026-09-09
10080196320424MEDLINEMDS30103MDS301032026-09-09
10080196320431MEDLINEMDS30104MDS301042026-09-09
10080196320509MEDLINEMDS30202MDS302022026-09-09
10080196320523MEDLINEMDS30204MDS302042026-09-09
10080196320530MEDLINEMDS30205MDS302052026-09-09
10080196320660MEDLINEMDS30301MDS303012026-09-09
10080196320721MEDLINEMDS30302MDS303022026-09-09
10080196320752MEDLINEMDS30303MDS303032026-09-09
10080196320790MEDLINEMDS30304MDS303042026-09-09
10080196320806MEDLINEMDS30305MDS303052026-09-09
10080196321179MEDLINEMDS30405MDS304052026-09-09
10080196321384MEDLINEMDS30603MDS306032026-09-14
10197344220083MEDLINEDYNJP2530TWLDYNJP2530TWL2026-09-18
10197344220090MEDLINEDYNJP2540TWLDYNJP2540TWL2026-09-18
10888277198739MEDLINEMDT821231QMDT821231Q2026-09-18
10888277688896MEDLINEMDS30106BMDS30106B2026-09-18
10888277688902MEDLINEMDS30107BMDS30107B2026-09-18
10888277688919MEDLINEMDS30108BMDS30108B2026-09-18
10888277688926MEDLINEMDS30109BMDS30109B2026-09-18

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