FDA UDI
In Commercial Distribution
🇺🇸 United States
Cocoon
DI: 09332017000041
·
Model: CLM 0202
·
CARE ESSENTIALS PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Cocoon
- Primary DI
- 09332017000041
- Version / Model
- CLM 0202
- Catalog Number
- CLM 0202
- Company Name
- CARE ESSENTIALS PTY LTD
- Labeler DUNS
- 745058946
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-01
- Public Version
- 2
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- d22b3263-9f05-482e-a585-91d6e5ef4ad9
Device Description
Cocoon Sterile Cardiac Blanket
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 47682 | Circulating-air whole-body heating/cooling system pad, single-use, sterile | A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 19332017000048 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 09332017000041 | GS1 |
Customer Contacts
- Phone
- +61352771455
- [email protected]