FDA.reportPublic FDA data

SecureSoft

Primary DI
00810053920251
Brand
SecureSoft
Company
COMPACTCATH, INC.
Model
SS16-2020
Catalog number
SS16-2020
Device description
SecureSoft Female External Catheter
Published
2026-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NZUCollector, Urine, Powered, Non Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZUCollector, Urine, Powered, Non Indwelling CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810053920258PackageGS130In Commercial Distribution
00810053920251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005392025810810053920258
00810053920251008100539202518100539202510810053920251

GMDN Terms#

Term, Definition table
TermDefinition
Female wearable urinal, single-useA non-sterile, urine drainage device designed for women that typically consists of a moulded collection cup, which may be partially inserted into the vagina, and a flexible tube attached to a collector that is specially formed to securely fit around the female genitals to provide a route to channel urine, via a tube, into a collection bag. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Catheter Working Length0

Regulatory Flags#

DUNS number
054765780
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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
00860016449404Vitawick Male External CatheterHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-09-05
00860016449411Vitawick Urine Collection SystemHK DAMISEN TECHNOLOGY CO., LIMITEDNZU2026-09-04
07333387055299Surity Urinary Management SystemWellspect ABNZU2026-08-18
07333387055305Surity Urinary Management Refresh KitWellspect ABNZU2026-08-18
07333387059198Surity Urinary Management System with BatteryWellspect ABNZU2026-08-18
07333387055367Surity Suction TubeWellspect ABNZU2026-07-13
07333387055398Surity Carbon FiltersWellspect ABNZU2026-07-13
07333387060446Surity Power AdapterWellspect ABNZU2026-07-13
00801741231025PureWickC. R. Bard, Inc.NZU2026-05-07
00801741234514PureWickC. R. Bard, Inc.NZU2026-05-07
00801741231537PureWickC. R. Bard, Inc.NZU2026-05-06
10801741239219PureWickC. R. Bard, Inc.NZU2026-05-05
07333387056623Surity Male External CatheterWellspect ABNZU2026-04-27
00801741231001PureWickC. R. Bard, Inc.NZU2026-02-06
00801741231018PureWickC. R. Bard, Inc.NZU2026-02-06
07333387056630Surity Female External CatheterWellspect ABNZU2025-12-19
07333387055329Surity Female External CatheterWellspect ABNZU2025-12-19
10816286021151BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
20816286021158BOEHRINGER® CareDry™ Male SystemBOEHRINGER LABORATORIES, LLCNZU2024-12-31
00801741226960PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226984PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226967PureWickC. R. Bard, Inc.NZU2024-07-29
10801741226981PureWickC. R. Bard, Inc.NZU2024-07-29
00801741226465PureWickC. R. Bard, Inc.NZU2024-05-31
00801741226953PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226462PureWickC. R. Bard, Inc.NZU2024-05-31
10801741226950PureWickC. R. Bard, Inc.NZU2024-05-31
07290109270203UriCap Base kit+ box of 30TILLA CARE LTDNZU2024-04-02
07290109270210UriCap Female + TILLA CARE LTDNZU2024-04-02
07290109270227Home Sample Kits (box of 5)TILLA CARE LTDNZU2024-04-02