FDA.reportPublic FDA data

UriCap Base kit+ box of 30

Primary DI
07290109270203
Brand
UriCap Base kit+ box of 30
Company
TILLA CARE LTD
Model
A
Catalog number
KIT00020-30
Published
2024-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07290109270203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109270203072901092702037290109270203

GMDN Terms#

Term, Definition table
TermDefinition
Urine transfer IVD, non-sterileA non-sterile plastic adaptor or dedicated transfer device, intended to be used to assist with the transfer of a urine specimen from the primary collection container to an evacuated urine specimen container for subsequent analysis and/or other investigation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600502332
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109270210UriCap Female + AFPR000082024-04-02
07290109270227Home Sample Kits (box of 5)AKIT00013-5H2024-04-02
07290109270234Home Base Kit (30-Day Supply)AKIT00013-30H2024-04-02
07290109270197Tube Connector BMEC000032023-10-02
07290109270173UriCap Base kit box of 30AKIT00013-302022-06-14
07290109270180UriCap Base kit box of 5AKIT00013-52022-06-14
07290109270135Urine bag - Tilla 2LAHRD000082022-02-06
07290109270142Demonstration box AKIT000102022-02-06
07290109270159Weekly BoxAKIT0000162022-02-06
07290109270166Monthly BoxAKIT0000172022-02-06
07290109270074Extension Tube SX - LAFPR000042021-12-27
07290109270081UriCap Female Starter kitAKIT000112021-12-27
07290109270098UriCap Female Change kitAKIT000122021-12-27
07290109270104UriCap Female Base kitAKIT000132021-12-27
07290109270128Securement Device AHRD000062021-12-27
07290109270067TillaCatch AFPR000032020-08-03
07290109270012UriCap Female Device CFPR02020L2019-12-31
07290109270029Extension Tube BFPR000012019-12-31
07290109270036UriCap Female 1 set BKIT000052019-12-31
07290109270043Extension Tube SXAFPR000022019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07290109270210UriCap Female + TILLA CARE LTDNZU2024-04-02
07290109270227Home Sample Kits (box of 5)TILLA CARE LTDNZU2024-04-02
07290109270234Home Base Kit (30-Day Supply)TILLA CARE LTDNZU2024-04-02
10816286021144BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
20816286021141BOEHRINGER® CareDry™ SystemBOEHRINGER LABORATORIES, LLCNZU2023-12-29
07290109270197Tube Connector TILLA CARE LTDNZU2023-10-02
00801741219153PureWick MaleC. R. Bard, Inc.NZU2022-08-01
10801741219150PureWick MaleC. R. Bard, Inc.NZU2022-08-01
07290109270173UriCap Base kit box of 30TILLA CARE LTDNZU2022-06-14
07290109270180UriCap Base kit box of 5TILLA CARE LTDNZU2022-06-14
00618029980069Streamline External Urine Management deviceSAGE PRODUCTS, LLCNZU2022-05-24