FDA.reportPublic FDA data

MEDLINE

Primary DI
20197344148988
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
URO4PVCPC16C
Catalog number
URO4PVCPC16C
Device description
TOTAL ONE LAYER INTERMITTENT
Published
2025-04-07
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

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
20197344148988PackageGS120In Commercial Distribution
10197344148981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734414898820197344148988
1019734414898110197344148981

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent urethral catheterization kitA collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing, Avoid excessive heat

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
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 DI, Brand, Company table
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