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Care Essentials Pty Ltd: FDA-registered device maker in North Geelong Victoria, Australia, 4 510(k) clearances

Name: Care Essentials Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Care Essentials Pty Ltd is registered with the FDA (registration 3011059079) in North Geelong Victoria, Australia. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 21, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011059079
Address: 103 Mornington Street, North Geelong Victoria, Australia, 3215
Owner or operator: CARE ESSENTIALS PTY LTD (10048196)
Roles: Manufacturer
First device listed: December 16, 2014
Registered through: 2026
Brand names listed: CareGUARD Sterilization Wrap, Cocoon Convective Warming System, Cocoon Convective Warming System, Model CWS7000, Sterile Cocoon Convective Warming System

Devices it lists

Device	Product code	Class	Role	Source
System, Thermal Regulating	DWJ	2	Manufacturer	accessdata.fda.gov
Wrap, Sterilization	FRG	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 21, 2024	K232502	Cocoon Convective Warming System, Model CWS7000	DWJ	Substantially Equivalent	Care Essentials Pty, Ltd.	accessdata.fda.gov
March 14, 2022	K213907	CareGUARD Sterilization Wrap	FRG	Substantially Equivalent	Care Essentials Pty, Ltd.	accessdata.fda.gov
May 2, 2019	K181671	Cocoon Convective Warming System	DWJ	Substantially Equivalent	Care Essentials Pty, Ltd.	accessdata.fda.gov
July 25, 2014	K140635	COCOON CONVECTIVE WARMING SYSTEM	DWJ	Substantially Equivalent	Care Essentials Pty, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 7, 2020	84541	Class II	Terminated	Cocoon Convective Warming System, Product Code: CWS4000 (110V).	Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.	accessdata.fda.gov

Compare with other makers

Updated February 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.