FDA.reportPublic FDA data

Intermittent Catheter

Primary DI
00616784499536
Brand
Intermittent Catheter
Company
DYNAREX CORPORATION
Model
4995
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZDCatheter, Straight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZDCatheter, StraightGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103086000DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRICDynarex Corporation2011-06-07EZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784499536PackageGS112In Commercial Distribution
00616784499529PrimaryGS10
00616784499512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784499536006167844995366167844995360616784499536
00616784499529006167844995296167844995290616784499529
00616784499512006167844995126167844995120616784499512

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage/irrigation catheterA sterile, flexible tube, typically with two lumens, designed to be inserted through the urethra and into the urinary bladder to provide one episode of irrigation and/or drainage of the bladder. It is typically inserted by a healthcare professional. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01
00616784206325Lab Coats Knitted Cuffs & Collar with Pockets, Medium, White20632021-09-01
00616784206424Lab Coats Knitted Cuffs & Collar with Pockets, Large, White20642021-09-01
00616784206523Lab Coats Knitted Cuffs & Collar with Pockets, X-Large, White20652021-09-01
00616784206622Lab Coats Knitted Cuffs & Collar with Pockets, 2X-Large, White20662021-09-01
00616784207223Lab Coats Knitted Cuffs & Collar with Pockets, Small, Blue20722021-09-01
00616784207322Lab Coats Knitted Cuffs & Collar with Pockets, Medium, Blue20732021-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00610075096152VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096169VaProHOLLISTER INCORPORATEDEZD2026-06-06
00610075096176VaProHOLLISTER INCORPORATEDEZD2026-06-06
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10197344162284MEDLINEMEDLINE INDUSTRIES, INC.EZD2025-09-22