FDA.reportPublic FDA data

OneCath

Primary DI
00852141007338
Brand
OneCath
Company
COMPACTCATH, INC.
Model
202-1612
Catalog number
1612
Device description
The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852141007338PrimaryGS10
00852141007581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852141007338008521410073388521410073380852141007338
00852141007581008521410075818521410075810852141007581

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge12French
Length16Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)933-2284support@compactcath.com

Regulatory Flags#

DUNS number
054765780
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810053920036OneCath Hydro2031-16142031-16142021-10-23
10810053920043OneCath Hydro2031-08122031-08122021-10-23
10810053920081OneCath Hydro2032-16142032-16142021-10-23
00810053920039OneCath Hydro2031-16142031-16142021-10-23
00810053920046OneCath Hydro2031-08122031-08122021-10-23
00810053920084OneCath Hydro2032-16142032-16142021-10-23
00852141007468OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007475OneCath201-1614 (30)1614(30)2021-09-25
00852141007925OneCath Lubricated2041-16142041-16142021-09-25
00852141007949OneCath Lubricated2042-16142042-16142021-09-25
00852141007079OneCath201-1612 (30) 1612 (30 pack)2021-09-25
00852141007109OneCath201-1614 (30)1614(30)2021-09-25
00852141007871OneCath Lubricated2041-16142041-16142021-09-25
00852141007895OneCath Lubricated2042-16142042-16142021-09-25
10852141007847COMPACTCATH Extension Tube1903-18321903-18322021-02-02
00852141007840COMPACTCATH Extension Tube1903-18321903-18322021-02-02
10852141007724COMPACTCATH - Lite1011-16161011-16162019-09-01
10852141007731COMPACTCATH - Lite1012-16161012-16162019-09-01
00852141007383COMPACTCATH - Lite1011-16121011-16122019-08-01
00852141007321COMPACTCATH - Lite1012-16141012-16142019-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704942456RUSCHTELEFLEX INCORPORATEDEZC2026-05-15
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
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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
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