FDA.reportPublic FDA data

OneCath Hydro

Primary DI
10810053920036
Brand
OneCath Hydro
Company
COMPACTCATH, INC.
Model
2031-1614
Catalog number
2031-1614
Device description
The OneCath-Hydro Hydrophilic 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
2021-10-23
Public version status
New
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
GBMCatheter, Urethral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBMCatheter, UrethralGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810053920036PrimaryGS10
00810053920039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005392003610810053920036
00810053920039008100539200398100539200390810053920039

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 Gauge14French
Length16Inch

Contacts#

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

Regulatory Flags#

DUNS number
054765780
Device count
30
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00852141007307COMPACTCATH - Lite1002-16141002-16142019-04-24

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