FDA.reportPublic FDA data

Red Rubber Urethral Catheters

Primary DI
00616784506524
Brand
Red Rubber Urethral Catheters
Company
Dynarex Corporation
Model
5065
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EYBCatheter, Ureteral, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092250000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092250000MEDLINE RED RUBBER URETHRAL CATHETERMedline Industries, Inc.2010-01-21EYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784506531PackageGS140In Commercial Distribution
00616784506524PrimaryGS10
00616784506517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784506531006167845065316167845065310616784506531
00616784506524006167845065246167845065240616784506524
00616784506517006167845065176167845065170616784506517

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25
00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25
00840117352186AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67242019-11-25
00616784894027LabChoice SecureSafety Safety Blood Collection Sets, Sterile,89402018-05-26
00616784894126LabChoice SecureSafety Safety Blood Collection Sets, Sterile89412018-05-26
00616784894225LabChoice SecureSafety Safety Blood Collection Sets, Sterile89422018-05-26
00616784010014Aluminum Crutches - Child101002019-09-30
00840117346505PA Safety Lancets, Pressure Activated, 21 G Needle71132026-06-01
00840117343788Dynacare HerCare Necessities Complete Kit13752026-05-29
00616784213132Shoe Cover Non-Conductive, Universal21312021-06-21
00616784213231Shoe Cover Non-Conductive, Non-Skid, Universal Size21322021-06-21
00616784213439Shoe Cover Non-Conductive, Non-Skid, X-Large21342021-06-21
00616784426518IV Pole Kit For Enteral Irrigation, Non-Sterile42652021-09-01
00616784562018DynaLift Transport Unit, White, 40" x 80" (101.6 cm x 203.2 cm)56202021-04-22
00616784562117DynaLift Transport Unit, Black, 40" x 80" (101.6 cm x 203.2 cm)56212021-04-22
00840117308992Resp-O2 Single Suction Catheter, 12 FR320032022-05-10
00840117309012Resp-O2 Single Suction Catheter, 14 FR320042022-05-10
00840117309036Resp-O2 Single Suction Catheter, 16 FR320052022-05-10
00840117309050Resp-O2 Single Suction Catheter, 18 FR320062022-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03600040963869ColoplastColoplast A/SEYB2026-01-30
03600040963920ColoplastColoplast A/SEYB2026-01-30
03600040964019ColoplastColoplast A/SEYB2026-01-30
03600040964071ColoplastColoplast A/SEYB2026-01-30
03600040964163ColoplastColoplast A/SEYB2026-01-30
03600040964224ColoplastColoplast A/SEYB2026-01-30
03600040964286ColoplastColoplast A/SEYB2026-01-30
03600040964347ColoplastColoplast A/SEYB2026-01-30
03600040964408ColoplastColoplast A/SEYB2026-01-30
03600040964644ColoplastColoplast A/SEYB2026-01-30
03600040965870ColoplastColoplast A/SEYB2026-01-30
03600040965931ColoplastColoplast A/SEYB2026-01-30
03600040965993ColoplastColoplast A/SEYB2026-01-30
03600040966051ColoplastColoplast A/SEYB2026-01-30
03600040966112ColoplastColoplast A/SEYB2026-01-30
03600040966204ColoplastColoplast A/SEYB2026-01-30
03600040966297ColoplastColoplast A/SEYB2026-01-30
03600040966389ColoplastColoplast A/SEYB2026-01-30
03600040966471ColoplastColoplast A/SEYB2026-01-30
03600040966532ColoplastColoplast A/SEYB2026-01-30
03600040966594ColoplastColoplast A/SEYB2026-01-30
03600040966655ColoplastColoplast A/SEYB2026-01-30
03600040966716ColoplastColoplast A/SEYB2026-01-30
03600040966778ColoplastColoplast A/SEYB2026-01-30
03600040966839ColoplastColoplast A/SEYB2026-01-30
03600040966891ColoplastColoplast A/SEYB2026-01-30
03600040966983ColoplastColoplast A/SEYB2026-01-30
03600040967041ColoplastColoplast A/SEYB2026-01-30
03600040967133ColoplastColoplast A/SEYB2026-01-30
03600040967195ColoplastColoplast A/SEYB2026-01-30