FDA.reportPublic FDA data

Red Rubber Urethral Catheters

Primary DI
00616784506722
Brand
Red Rubber Urethral Catheters
Company
Dynarex Corporation
Model
5067
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
00616784506739PackageGS140In Commercial Distribution
00616784506722PrimaryGS10
00616784506715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784506739006167845067396167845067390616784506739
00616784506722006167845067226167845067220616784506722
00616784506715006167845067156167845067150616784506715

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
00840117305670Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric310012021-04-22
00840117305694Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310022021-04-22
00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305779Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310212021-04-22
00840117305786Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult310222021-04-22
00840117305809Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310322021-04-22
00840117318144Resp-O2 Closed Suction Endotracheal Catheters, Sterile310202021-04-22
00840117318168Resp-O2 Closed Suction Endotracheal Catheter Double Swivel Elbow (DSE)310302021-04-22
00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319523Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310332021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
00840117344129Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric310042025-10-27
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Pediatric310242026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310252026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult310262026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310342026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310352026-05-18

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