FDA.reportPublic FDA data

Cocoon

Primary DI
09332017002991
Brand
Cocoon
Company
CARE ESSENTIALS PTY LTD
Model
CLM 0127P
Catalog number
CLM 0127P
Device description
Cocoon Adult Full Access Under Body
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19332017002998PackageGS110In Commercial Distribution
09332017002991PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933201700299819332017002998
09332017002991093320170029919332017002991

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-air core temperature regulation system pad, single-useAn 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.

Contacts#

Phone, Email table
PhoneEmail
+61352771455queries@careessentials.com.au

Regulatory Flags#

DUNS number
745058946
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09332017004131CocoonCLM 0105-TPCLM 0105-TP2026-02-25
09332017004155CocoonCLM 0107-TPCLM 0107-TP2026-02-25
19332017004138CocoonCLM 0105-TPCLM 0105-TP2026-02-25
19332017004152CocoonCLM 0107-TPCLM 0107-TP2026-02-25
09332017003264Cocoon Convective Warming Machine, Model CWS7000CWS7000CWS7000-1102024-04-04
09332017000553CocoonCWS 4000CWS4000-1102021-03-01
09332017002007CocoonCWS 5000CWS5000-1102021-03-01
09332017002861CocoonCLM 0120CLM 01202024-12-20
09332017000041CocoonCLM 0202CLM 02022021-03-01
09332017000669CareGUARDSW606050-B/BSW606050-B/B2022-04-06
09332017000676CareGUARDSW10010050-BSW10010050-B2022-04-06
09332017000683CareGUARDSW606060-B/BSW606060-B/B2022-04-06
09332017000690CareGUARDSW606075-B/BSW606075-B/B2022-04-06
09332017001222CareGUARDSW606060-BSW606060-B2022-04-06
09332017001437CareGUARDSW606050-BSW606050-B2022-04-06
09332017001444CareGUARDSW606075-BSW606075-B2022-04-06
09332017001451CareGUARDSW10010050-B/BSW10010050-B/B2022-04-06
09332017001468CareGUARDSW10010060-B/BSW10010060-B/B2022-04-06
09332017001475CareGUARDSW10010060-BSW10010060-B2022-04-06
09332017001482CareGUARDSW10010075-B/BSW10010075-B/B2022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09332017004131CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
09332017004155CocoonCARE ESSENTIALS PTY LTDDWJ2026-02-25
10197344129072MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
10197344129089MEDLINEMEDLINE INDUSTRIES, INC.DWJ2025-05-07
08719867002639Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
08719867002653Mistral-AirThe Surgical Company International B.V.DWJ2025-01-30
09332017002861CocoonCARE ESSENTIALS PTY LTDDWJ2024-12-20
09332017003257CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003295CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003301CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003318CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003325CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003332CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
09332017003349CocoonCARE ESSENTIALS PTY LTDDWJ2024-09-13
08719867002646Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
08719867002660Mistral-Air®The Surgical Company International B.V.DWJ2024-07-08
10193489134773MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134780MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10193489134797MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012770MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012817MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012831MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344013401MEDLINEMEDLINE INDUSTRIES, INC.DWJ2024-06-25
10197344012794MedlineMEDLINE INDUSTRIES, INC.DWJ2024-04-30
09332017002885CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017002892CocoonCARE ESSENTIALS PTY LTDDWJ2023-01-20
09332017000645CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017002168CocoonCARE ESSENTIALS PTY LTDDWJ2021-08-04
09332017001178CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01
09332017001192CocoonCARE ESSENTIALS PTY LTDDWJ2021-06-01