FDA.reportPublic FDA data

RUSCH

Primary DI
14026704942456
Brand
RUSCH
Company
TELEFLEX INCORPORATED
Model
221800-000160
Catalog number
221800-000160
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZCCATHETER, COUDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222279000Rusch Intermittent Urethral CathetersTeleflex Medical2022-08-29EZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704942459PackageGS150In Commercial Distribution
24026704942453PackageGS112In Commercial Distribution
14026704942456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704942459040267049424594026704942459
2402670494245324026704942453
1402670494245614026704942456

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24
15060112315043LMA AIRWAY MANAGEMENTIPN0487821280502026-06-24
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704942463RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942470RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942487RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942494RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942500RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
14026704942517RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
10854913006195Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-17
10854913006157Urinary Catheter, 16 FrUROGEN PHARMA LTDEZC2025-11-16
10854913006119Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10854913006126Urinary CatheterUROGEN PHARMA LTDEZC2022-06-01
10852141007731COMPACTCATH - LiteCOMPACTCATH, INC.EZC2019-09-01
00801741040665Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040672Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040689Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040696Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040702Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741040719Bardex® Lubricath® Hydrogel-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046520Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046537Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741046544Bardex® Silicone Elastomer-Coated Foley Catheter KitC. R. Bard, Inc.EZC2016-08-16
00801741017735Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017742Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741017759Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019333Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741019340Bard® CritiCore® Surgipack® with Bardex® LubriCath® Temp Sensing CatheterC. R. Bard, Inc.EZC2016-08-06
00801741039096Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741039102Bardia® Coude Olive Tip Urethral Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040238Bard® Foley Catheter Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040252Bard® Urine Meter Foley Tray With Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28
00801741040313Bard® Foley Tray with Bard® Hydrophilic-Coated Foley CatheterC. R. Bard, Inc.EZC2016-07-28