Care Essentials Pty L T D

FDA Filings

This page includes the latest FDA filings for Care Essentials Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011059079
• FEI Number: 3011059079
• Name: Bruce Heymann
• Owner & Operator: CARE ESSENTIALS PTY LTD
• Contact Address: 25 Slevin Street ; North Geelong AU-VIC Victoria 3215 AU
• Official Correspondent:
  • ABHAY SINHA
  • 61-3-52771455-x
• US Agent:
  • Bruce Heymann
  • Medical Solutions, Inc.
  • 703 7361638
  • brheymann@aol.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3901 Centerview Dr. Suite L; Chantilly, VA 20151 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3011682049
• FEI Number: 3011682049
• Name: CARE ESSENTIALS INTERNATIONAL PVT LTD.
• Owner & Operator: CARE ESSENTIALS PTY LTD
• Contact Address: 25 Slevin Street ; North Geelong AU-VIC Victoria 3215 AU
• Official Correspondent:
  • ABHAY SINHA
  • 61-3-52771455-x
• US Agent:
  • Bruce Heymann
  • Medical Solutions, Inc.
  • 703 7361638
  • brheymann@aol.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: B-9 Shekhar Appartment Mayur Vihar, Phase-1 Extention; New Delhi Delhi, 110091 IN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 19332017003346 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145S-K	2024-09-23
GUDID 19332017003339 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145R-K	2024-09-23
GUDID 19332017003322 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145L-K	2024-09-23
GUDID 19332017003315 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145S	2024-09-23
GUDID 19332017003308 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145R	2024-09-23
GUDID 19332017003292 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145L	2024-09-23
GUDID 19332017003254 CARE ESSENTIALS PTY LTD	Cocoon CLM 0147	2024-09-23
GUDID 09332017003264 CARE ESSENTIALS PTY LTD	Cocoon Convective Warming Machine, Model CWS7000 CWS7000	2024-04-12
GUDID 19332017002899 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145K	2023-12-18
GUDID 19332017002882 CARE ESSENTIALS PTY LTD	Cocoon CLM 0145	2023-12-18
GUDID 19332017002202 CARE ESSENTIALS PTY LTD	CareGUARD SW13718275-B/W	2022-04-14
GUDID 19332017002196 CARE ESSENTIALS PTY LTD	CareGUARD SW13718260-B/W	2022-04-14
GUDID 19332017002097 CARE ESSENTIALS PTY LTD	CareGUARD SW606075-B/W	2022-04-14
GUDID 19332017002080 CARE ESSENTIALS PTY LTD	CareGUARD SW10010075-B/W	2022-04-14
GUDID 19332017002073 CARE ESSENTIALS PTY LTD	CareGUARD SW12012075-B/W	2022-04-14
GUDID 19332017002066 CARE ESSENTIALS PTY LTD	CareGUARD SW606060-B/W	2022-04-14
GUDID 19332017002059 CARE ESSENTIALS PTY LTD	CareGUARD SW10010060-B/W	2022-04-14
GUDID 19332017002042 CARE ESSENTIALS PTY LTD	CareGUARD SW12012060-B/W	2022-04-14
GUDID 19332017002035 CARE ESSENTIALS PTY LTD	CareGUARD SW606050-B/W	2022-04-14
GUDID 19332017002028 CARE ESSENTIALS PTY LTD	CareGUARD SW10010050-B/W	2022-04-14
GUDID 19332017002011 CARE ESSENTIALS PTY LTD	CareGUARD SW12012050-B/W	2022-04-14
GUDID 19332017001991 CARE ESSENTIALS PTY LTD	CareGUARD SW13718250-B/W	2022-04-14
GUDID 19332017001984 CARE ESSENTIALS PTY LTD	CareGUARD SW13718275-B/B	2022-04-14
GUDID 19332017001977 CARE ESSENTIALS PTY LTD	CareGUARD SW13718260-B/B	2022-04-14
GUDID 19332017001960 CARE ESSENTIALS PTY LTD	CareGUARD SW13718250-B/B	2022-04-14
GUDID 19332017001953 CARE ESSENTIALS PTY LTD	CareGUARD SW13718275-B	2022-04-14
GUDID 19332017001946 CARE ESSENTIALS PTY LTD	CareGUARD SW13718260-B	2022-04-14
GUDID 19332017001939 CARE ESSENTIALS PTY LTD	CareGUARD SW13718250-B	2022-04-14
GUDID 19332017001922 CARE ESSENTIALS PTY LTD	CareGUARD SW13713775-B/W	2022-04-14
GUDID 19332017001915 CARE ESSENTIALS PTY LTD	CareGUARD SW13713760-B/W	2022-04-14
GUDID 19332017001908 CARE ESSENTIALS PTY LTD	CareGUARD SW13713750-B/W	2022-04-14
GUDID 19332017001892 CARE ESSENTIALS PTY LTD	CareGUARD SW13713775-B/B	2022-04-14
GUDID 19332017001885 CARE ESSENTIALS PTY LTD	CareGUARD SW13713760-B/B	2022-04-14
GUDID 19332017001878 CARE ESSENTIALS PTY LTD	CareGUARD SW13713750-B/B	2022-04-14
GUDID 19332017001861 CARE ESSENTIALS PTY LTD	CareGUARD	2022-04-14
GUDID 19332017001854 CARE ESSENTIALS PTY LTD	CareGUARD SW13713760-B	2022-04-14
GUDID 19332017001847 CARE ESSENTIALS PTY LTD	CareGUARD SW13713750-B	2022-04-14
GUDID 19332017001830 CARE ESSENTIALS PTY LTD	CareGUARD SW11611675-B/W	2022-04-14
GUDID 19332017001823 CARE ESSENTIALS PTY LTD	CareGUARD SW11611660-B/W	2022-04-14
GUDID 19332017001816 CARE ESSENTIALS PTY LTD	CareGUARD SW11611650-B/W	2022-04-14
GUDID 19332017001809 CARE ESSENTIALS PTY LTD	CareGUARD SW11611675-B/B	2022-04-14
GUDID 19332017001793 CARE ESSENTIALS PTY LTD	CareGUARD SW11611660-B/B	2022-04-14
GUDID 19332017001786 CARE ESSENTIALS PTY LTD	CareGUARD SW11611650-B/B	2022-04-14
GUDID 19332017001779 CARE ESSENTIALS PTY LTD	CareGUARD SW11611675-B	2022-04-14
GUDID 19332017001762 CARE ESSENTIALS PTY LTD	CareGUARD SW11611660-B	2022-04-14
GUDID 19332017001755 CARE ESSENTIALS PTY LTD	CareGUARD SW11611650-B	2022-04-14
GUDID 19332017001731 CARE ESSENTIALS PTY LTD	CareGUARD SW919175-B/W	2022-04-14
GUDID 19332017001724 CARE ESSENTIALS PTY LTD	CareGUARD SW919160-B/W	2022-04-14
GUDID 19332017001717 CARE ESSENTIALS PTY LTD	CareGUARD SW919150-B/W	2022-04-14
GUDID 19332017001700 CARE ESSENTIALS PTY LTD	CareGUARD SW919175-B/B	2022-04-14
GUDID 19332017001694 CARE ESSENTIALS PTY LTD	CareGUARD SW919160-B/B	2022-04-14
GUDID 19332017001687 CARE ESSENTIALS PTY LTD	CareGUARD SW919150-B/B	2022-04-14
GUDID 19332017001670 CARE ESSENTIALS PTY LTD	CareGUARD SW919175-B	2022-04-14
GUDID 19332017001663 CARE ESSENTIALS PTY LTD	CareGUARD SW919160-B	2022-04-14
GUDID 19332017001656 CARE ESSENTIALS PTY LTD	CareGUARD SW919150-B	2022-04-14
GUDID 19332017001649 CARE ESSENTIALS PTY LTD	CareGUARD SW767675-B/B	2022-04-14
GUDID 19332017001632 CARE ESSENTIALS PTY LTD	CareGUARD SW767660-B/B	2022-04-14
GUDID 19332017001625 CARE ESSENTIALS PTY LTD	CareGUARD SW767650-B/B	2022-04-14
GUDID 19332017001618 CARE ESSENTIALS PTY LTD	CareGUARD SW767675-B	2022-04-14
GUDID 19332017001601 CARE ESSENTIALS PTY LTD	CareGUARD SW767660-B	2022-04-14
GUDID 19332017001595 CARE ESSENTIALS PTY LTD	CareGUARD SW767650-B	2022-04-14
GUDID 19332017001588 CARE ESSENTIALS PTY LTD	CareGUARD SW767675-B/W	2022-04-14
GUDID 19332017001571 CARE ESSENTIALS PTY LTD	CareGUARD SW767660-B/W	2022-04-14
GUDID 19332017001564 CARE ESSENTIALS PTY LTD	CareGUARD SW767650-B/W	2022-04-14
GUDID 19332017001557 CARE ESSENTIALS PTY LTD	CareGUARD SW12012075-B	2022-04-14
GUDID 19332017001540 CARE ESSENTIALS PTY LTD	CareGUARD SW12012075-B/B	2022-04-14
GUDID 19332017001533 CARE ESSENTIALS PTY LTD	CareGUARD SW12012060-B	2022-04-14
GUDID 19332017001526 CARE ESSENTIALS PTY LTD	CareGUARD SW12012060-B/B	2022-04-14
GUDID 19332017001519 CARE ESSENTIALS PTY LTD	CareGUARD SW12012050-B	2022-04-14
GUDID 19332017001502 CARE ESSENTIALS PTY LTD	CareGUARD SW12012050-B/B	2022-04-14
GUDID 19332017001496 CARE ESSENTIALS PTY LTD	CareGUARD SW10010075-B	2022-04-14
GUDID 19332017001489 CARE ESSENTIALS PTY LTD	CareGUARD SW10010075-B/B	2022-04-14
GUDID 19332017001472 CARE ESSENTIALS PTY LTD	CareGUARD SW10010060-B	2022-04-14
GUDID 19332017001465 CARE ESSENTIALS PTY LTD	CareGUARD SW10010060-B/B	2022-04-14
GUDID 19332017001458 CARE ESSENTIALS PTY LTD	CareGUARD SW10010050-B/B	2022-04-14
GUDID 19332017001441 CARE ESSENTIALS PTY LTD	CareGUARD SW606075-B	2022-04-14
GUDID 19332017001434 CARE ESSENTIALS PTY LTD	CareGUARD SW606050-B	2022-04-14
GUDID 19332017001229 CARE ESSENTIALS PTY LTD	CareGUARD SW606060-B	2022-04-14
GUDID 19332017000697 CARE ESSENTIALS PTY LTD	CareGUARD SW606075-B/B	2022-04-14
GUDID 19332017000680 CARE ESSENTIALS PTY LTD	CareGUARD SW606060-B/B	2022-04-14
GUDID 19332017000673 CARE ESSENTIALS PTY LTD	CareGUARD SW10010050-B	2022-04-14
GUDID 19332017000666 CARE ESSENTIALS PTY LTD	CareGUARD SW606050-B/B	2022-04-14
PMN K213907 Care Essentials Pty Ltd	CareGUARD Sterilization Wrap	2022-03-14
GUDID 19332017002165 CARE ESSENTIALS PTY LTD	Cocoon CLM 143K	2021-08-12
GUDID 19332017000642 CARE ESSENTIALS PTY LTD	Cocoon CLM 0105L	2021-08-12
GUDID 09332017002106 CARE ESSENTIALS PTY LTD	Cocoon CLM 095K	2021-08-12
GUDID 09332017001390 CARE ESSENTIALS PTY LTD	Cocoon CLM 0143	2021-06-09
GUDID 09332017001246 CARE ESSENTIALS PTY LTD	Cocoon CLM 0113	2021-06-09
GUDID 09332017001215 CARE ESSENTIALS PTY LTD	Cocoon CLM 0142	2021-06-09
GUDID 09332017001185 CARE ESSENTIALS PTY LTD	Cocoon CLM 0141	2021-06-09
GUDID 09332017001000 CARE ESSENTIALS PTY LTD	Cocoon CLM 0137	2021-03-10
GUDID 19332017000048 CARE ESSENTIALS PTY LTD	Cocoon CLM 0202	2021-03-09
GUDID 09332017002007 CARE ESSENTIALS PTY LTD	Cocoon CWS 5000	2021-03-09
GUDID 09332017001024 CARE ESSENTIALS PTY LTD	Cocoon CLM 0138	2021-03-09
GUDID 09332017000553 CARE ESSENTIALS PTY LTD	Cocoon CWS 4000	2021-03-09
GUDID 09332017000331 CARE ESSENTIALS PTY LTD	Cocoon CLM 0106	2021-03-08
GUDID 09332017000324 CARE ESSENTIALS PTY LTD	Cocoon CLM 0105	2021-03-08
GUDID 09332017000317 CARE ESSENTIALS PTY LTD	Cocoon CLM 0104	2021-03-08
GUDID 09332017000300 CARE ESSENTIALS PTY LTD	Cocoon CLM 0103	2021-03-08
GUDID 09332017000294 CARE ESSENTIALS PTY LTD	Cocoon CLM 0102	2021-03-08
GUDID 09332017000287 CARE ESSENTIALS PTY LTD	Cocoon CLM 0101	2021-03-08
PMN K181671 | DWJ Bruce Heymann [CARE ESSENTIALS PTY LTD]	Sterile Cocoon Convective Warming System	2019-05-06
PMN K181671 Care Essentials Pty Ltd	Cocoon Convective Warming System	2019-05-02
PMN K140635 | DWJ CARE ESSENTIALS INTERNATIONAL PVT LTD. [CARE ESSENTIALS PTY LTD]	Cocoon Convective Warming System	2014-12-16
PMN K140635 | DWJ Bruce Heymann [CARE ESSENTIALS PTY LTD]	Cocoon Convective Warming System	2014-12-16
PMN K140635 CARE ESSENTIALS PTY LTD	COCOON CONVECTIVE WARMING SYSTEM	2014-07-25

Related Finance Registrations

NCAGE Code	Z0HX6	CARE ESSENTIALS PTY LTD
CAGE Code	Z0HX6	CARE ESSENTIALS PTY LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019043055504	Cristobal,Panama -> Savannah, Georgia	PATIENT WARMING MACHINES AND ACCESSORIES	20 PKG
2018080263542	Algeciras,Spain -> Baltimore, Maryland	1X40 HQ FCL 20 PALLETS NON WOVEN WARMING BLANKETS (PATIE NT WARMING BLANKETS FOR HOSPIT AL USE) 2540 BOXES PACKED IN 20 PALLET INVOICE NO. CEIPL/ E/18-19/038 DATED 27.06.2018 SB NO: 5887878 DATE 29.06.2018	20 PKG
2018072337858	Algeciras,Spain -> Baltimore, Maryland	1X20 FCL 1160 BOXES PACKED IN 10 PALLET NON WOVEN BLANKETS FOR MEDICAL USE INVOICE NO. CEIPL/D/18-19/030 DATED 12.06. 2018 SB NO: 5518903 DATE 12.0 6.2018 HS CODE NO. 90189099 NET WT.4415.000KGS CEIPL	1160 BOX
2018071614127	Yarraville,Australia -> Long Beach, California	STC MEDICAL EQUIPMENT	320 PCS
201804126014	Nhava Sheva,India -> Norfolk, Virginia	. 1 X 20'ST CONTAINER TOTAL 10 PACKAGES ONLY TOTAL TEN PACKAGES ONLY NON WOVEN BLANKETS FOR MEDICAL USE 1100 BOXES PACKED IN 10 PACKAGES INVOICE NO. CEIPL/D/17-18/070	10 PCS
201804108189	Nhava Sheva,India -> Norfolk, Virginia	. 1 X 20'ST CONTAINER TOTAL 10 PACKAGES ONLY TOTAL TEN PACKAGES ONLY NON WOVEN BLANKETS FOR MEDICAL USE 1100 BOXES PACKED IN 10 PACKAGES INVOICE NO. CEIPL/D/17-18/070	10 PCS
2018032118397	Nhava Sheva,India -> Norfolk, Virginia	. 1 X 20'ST CONTAINER TOTAL 10 BOXES ONLY TOTAL TEN BOXES ONLY NON WOVEN BLANKETS FOR MEDICAL USE 940 BOXES PACKED IN 10 PACKAGES INVOICE NO.CEIPL/D/17-18/067	10 PCS