FDA.report

Medline

Primary DI
40889942467137
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
URO170218C
Catalog number
URO170218C
Device description
TTL1LYR 18FR10ML LATEX C UM TR
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OHRCatheter care tray

Product Code Classifications

CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40889942467137PackageGS110In Commercial Distribution
10889942467136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4088994246713740889942467137
1088994246713610889942467136

GMDN Terms

TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). 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
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10080196163885MEDLINENONTH100BNONTH100B2026-03-24
10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10854913006201Intravesical Administration Kit UROGEN PHARMA LTDOHR2026-03-15
50850058254680TruAdvance™HR PHARMACEUTICALS INC.OHR2026-03-06
50850045818468TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818475TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818482TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
00850063139366Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139373Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139380Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139397Neil Medical Group Neil Medical GroupOHR2025-12-08
50198956214567CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
50850058254888TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254895TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254901TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254918TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254925TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254932TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254949TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254956TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254963TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50198956094374CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
50850058254765TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254970TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254987TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254857TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254864TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254871TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254826TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254833TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254840TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
10854913006171Intravesical Administration KitUROGEN PHARMA LTDOHR2025-06-16