Identity
- Trade Name
- Large Paediatric Underbody EUDAMEDCocoon FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Cocoon Patient Warming Blanket EUDAMEDCocoon Large Paediatric - Under Body FDA UDI
- Model / Reference
- CLM 0115 EUDAMEDFDA UDI
- Description
- Cocoon Large Paediatric - Under Body FDA UDI
Identifiers
- Catalog Number
- CLM 0115 FDA UDI
- Primary DI / UDI-DI
- 09332017000102 EUDAMEDFDA UDI
- Basic UDI-DI
- 09332017CLM0EQ EUDAMED
- Direct Marketing DI
- 09332017000102 EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- T030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use FDA UDI
Classification
- Device Class
- Class 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
EUDAMEDFDA 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Large Paediatric Underbody by Care Essentials Pty Ltd — Class I — 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 | 09332017CLM0EQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED 9f55cba2-4a16-429e-b52e-19c8f7f583ae 61 fields · synced Jul 8, 2026
- FDA UDI 6a315ec4-9554-4516-8cdc-8fc34ec34f88 35 fields · synced May 30, 2026