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Cocoon Convective Warming System - CWS 5000
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CWS5000-220Model CWS 5000Ref CLM 0202
Identity
- Trade Name
- Cocoon Convective Warming System - CWS 5000 EUDAMEDCocoon EUDAMEDFDA UDI
- Generic Name
- Circulating-air whole-body heating/cooling system pad, single-use, sterile FDA UDI
- Device Name
- Convective Patient Warming Machine EUDAMEDDisposable Sterile Cardiac Blanket EUDAMEDCocoon Sterile Cardiac Blanket FDA UDI
- Model / Reference
- CWS 5000 EUDAMEDCWS5000-220 EUDAMEDCLM 0202 EUDAMEDFDA UDI
- Description
- Cocoon Sterile Cardiac Blanket FDA UDI
Identifiers
- Catalog Number
- CLM 0202 FDA UDI
- Primary DI / UDI-DI
- 09332017004087 EUDAMED09332017000041 EUDAMEDFDA UDI
- Basic UDI-DI
- 09332017CWS5HB EUDAMED09332017CLM1ES EUDAMED
- Direct Marketing DI
- 09332017004087 EUDAMED09332017000041 EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- Z12040208 BODY THERMOREGULATION EQUIPMENT EUDAMEDT030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- Circulating-air whole-body heating/cooling system pad, single-use, sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDEUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cocoon Convective Warming System - CWS 5000 by Care Essentials Pty Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 09332017CWS5HB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Care Essentials Pty Ltd
- EUDAMED SRN
- AU-MF-000009150
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 9a48fe75-8df1-4d1c-8724-60ca4df1e61f 61 fields · synced Jul 9, 2026
- FDA UDI d22b3263-9f05-482e-a585-91d6e5ef4ad9 35 fields · synced May 30, 2026
- EUDAMED 5d5b9021-1e74-4a68-af5e-d9c3e8921468 61 fields · synced Jul 9, 2026