FDA.report

Medline Industries, Inc.

Primary DI
40193489830072
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
URO170814CG
Catalog number
URO170814CG
Device description
14FR COUDE URINEMETER TRAY GRP
Published
2022-07-11
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
40193489830072PackageGS110In Commercial Distribution
10193489830071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019348983007240193489830072
1019348983007110193489830071

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463customerservice@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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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