FDA UDI
In Commercial Distribution
🇺🇸 United States
Cocoon Convective Warming Machine, Model CWS7000
DI: 09332017003264
·
Model: CWS7000
·
CARE ESSENTIALS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cocoon Convective Warming Machine, Model CWS7000
- Primary DI
- 09332017003264
- Version / Model
- CWS7000
- Catalog Number
- CWS7000-110
- Company Name
- CARE ESSENTIALS PTY LTD
- Labeler DUNS
- 745058946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-04
- Public Version
- 2
- Public Version Date
- 2025-07-02
- Public Version Status
- Update
- Public Device Record Key
- b3f5a078-b5fc-4167-865b-a9a2bfb32538
Device Description
Cocoon Convective Warming Machine, Model CWS7000
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DWJ | System, Thermal Regulating | Cardiovascular | 870.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36954 | Circulating-air whole-body heating system control unit | A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09332017003264 | GS1 |
Customer Contacts
- Phone
- 0352771455
- [email protected]