FDA.reportPublic FDA data

Cocoon

Primary DI
09332017000041
Brand
Cocoon
Company
CARE ESSENTIALS PTY LTD
Model
CLM 0202
Catalog number
CLM 0202
Device description
Cocoon Sterile Cardiac Blanket
Published
2021-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
19332017000048PackageGS110In Commercial Distribution
09332017000041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933201700004819332017000048
09332017000041093320170000419332017000041

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating/cooling system pad, single-use, sterileA 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.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09332017002991CocoonCLM 0127PCLM 0127P2026-04-29
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
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
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323380NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30