CARE ESSENTIALS PTY LTD

Address:103 Mornington Street,North Geelong Victoria,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Thermal Regulating (DWJ) (6) Wrap, Sterilization (FRG) (4)

Premarket Exempt

Clear

Cocoon - 09332017000645 Catalog Number : CLM 0105L

Device Description : Cocoon Paediatric – Neonatal (Left Port)

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Cocoon - 09332017000652 Catalog Number : CLM 0137

Device Description : Cocoon Lithotomy Under Body

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

CareGUARD - 09332017000669 Catalog Number : SW606050-B/B

Device Description : CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 50GSM, Blue/blue

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

CareGUARD - 09332017000676 Catalog Number : SW10010050-B

Device Description : CareGUARD Single Layer, 100cm x 100cm (40" x 40"), 50GSM, Blue

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

CareGUARD - 09332017000683 Catalog Number : SW606060-B/B

Device Description : CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 60GSM, Blue/blue

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

CareGUARD - 09332017000690 Catalog Number : SW606075-B/B

Device Description : CareGUARD Dual Layers, 60cm x 60cm (24" x 24"), 75GSM, Blue/blue

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 1

Cocoon - 09332017000706 Catalog Number : CLM 099

Device Description : Cocoon Disposable Full Pre-Warming Gown Blanket S

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Cocoon - 09332017000720 Catalog Number : CLM 097

Device Description : Cocoon Disposable Full Pre-Warming Gown Blanket L

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Cocoon - 09332017000744 Catalog Number : CLM 098

Device Description : Cocoon Disposable Full Pre-Warming Gown Blanket M

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

Cocoon - 09332017000768 Catalog Number : CLM 096

Device Description : Cocoon Disposable Full Pre-Warming Gown Blanket XL

Device Class : 2

Duns Number: 745058946

Premarket Exempt : No

Product Code : DWJ

Prescription Use : Yes

Device Count : 1

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