Cocoon

Basic Information

• Brand Name: Cocoon
• Primary DI: 09332017001277
• Version / Model: CLM 098K
• Catalog Number: CLM 098K
• Company Name: CARE ESSENTIALS PTY LTD
• Labeler DUNS: 745058946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-26
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 938043e8-13e2-4a4d-80bc-04a57ca4c16d

Device Description

Cocoon Disposable Full Pre-Warming Gown Blanket M with Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
47681	External circulating-air core temperature regulation system pad, single-use	An underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09332017001284	GS1	Carton	10	In Commercial Distribution
Primary	09332017001277	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]