FDA.reportPublic FDA data

Monthly Box

Primary DI
07290109270166
Brand
Monthly Box
Company
TILLA CARE LTD
Model
A
Catalog number
KIT000017
Published
2022-02-06
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
07290109270166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109270166072901092701667290109270166

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
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109270203UriCap Base kit+ box of 30AKIT00020-302024-04-02
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
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
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
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