Securement Device HRD00006

GUDID 07290109270128

Product GMCSD1001 , manufacture for Greystone medical

TILLA CARE LTD

Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile Urine transfer IVD, non-sterile
Primary Device ID07290109270128
NIH Device Record Key71dbd531-ad2c-4ab3-b3ab-d8947d19e8d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSecurement Device
Version Model NumberA
Catalog NumberHRD00006
Company DUNS600502332
Company NameTILLA CARE LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109270128 [Primary]

FDA Product Code

NZUCollector, Urine, Powered, Non Indwelling Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-04
Device Publish Date2021-12-27

Devices Manufactured by TILLA CARE LTD

07290109270203 - UriCap Base kit+ box of 302024-04-10
07290109270210 - UriCap Female + 2024-04-10
07290109270227 - Home Sample Kits (box of 5)2024-04-10
07290109270234 - Home Base Kit (30-Day Supply)2024-04-10
07290109270197 - Tube Connector 2023-10-10
07290109270173 - UriCap Base kit box of 302022-06-22
07290109270180 - UriCap Base kit box of 52022-06-22
07290109270135 - Urine bag - Tilla 2L2022-02-14

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