510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Care Essentials Pty., Ltd.

North Geelong Victoria, AU

CARE ESSENTIALS PTY LTD appears in FDA device records in North Geelong Victoria, AU. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 4 510(k) clearances for Care Essentials Pty., Ltd. between 2014 and 2024. The busiest year on record is 2014, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Care Essentials Pty., Ltd., by decision year
YearClearances
20141
20191
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232502Cocoon Convective Warming System, Model CWS7000DWJSubstantially Equivalent
K213907CareGUARD Sterilization WrapFRGSubstantially Equivalent
K181671Cocoon Convective Warming SystemDWJSubstantially Equivalent
K140635COCOON CONVECTIVE WARMING SYSTEMDWJSubstantially Equivalent

Registered establishments

FDA registered establishments for Care Essentials Pty., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30110590793011059079CARE ESSENTIALS PTY LTD103 Mornington Street, North Geelong Victoria 3215 AU2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0987-2020Cocoon Convective Warming System, Product Code: CWS5000 (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.Class IITerminated
Z-0986-2020Cocoon 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain