Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012315097

FEI Number

3012315097

Entity Name

CARE ESSENTIALS INTERNATIONAL PVT LTD.

City/State/Country

Ahmedabad Gujarat, IN

Establishment Address

Naman Estate, Building No. 2, Survey No 527 & 528, Opposite Pharmez, MatodaTaluka Sanand, NH 8A, Ahmedabad Gujarat 382213, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CARE ESSENTIALS PTY LTD (Owner Number: 10048196)

Owner / Operator Contact Address

103 Mornington Street, North Geelong, AU-VIC 3215, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cocoon Convective Warming System, Model CWS7000 Sterile Cocoon Convective Warming System Cocoon Convective Warming System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2024-03-18
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2019-05-06
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2014-12-16

Official Correspondent

ABHAY SINHA

US Agent Details

Manny Sok Business: Medical Solutions, Inc. Email: msok@msi-healthcare.com Phone: (703) 9957179

Related Public Records

Same Entity

CARE ESSENTIALS PTY LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011059079	CARE ESSENTIALS PTY LTD	North Geelong Victoria, AU
3034393266	Geelong Healthcare Manufacturing Pvt Ltd	Ahmedabad Gujarat, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number	Establishment Name	Location
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
2432320	NOVAMED-USA	Elmsford, NY, US
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
1060680	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012315097. Last updated year: 2026. Please use registration number 3012315097 when referencing this establishment in official correspondence.