FDA.reportPublic FDA data

CareGUARD

Primary DI
09332017001451
Brand
CareGUARD
Company
CARE ESSENTIALS PTY LTD
Model
SW10010050-B/B
Catalog number
SW10010050-B/B
Device description
"CareGUARD Dual Layers, 100cm x 100cm (40"" x 40""), 50GSM, Blue/blue"
Published
2022-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19332017001458PackageGS150In Commercial Distribution
09332017001451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933201700145819332017001458
09332017001451093320170014519332017001451

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. 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
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
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
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
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00840456215197JMUJMU DENTAL, INCFRG2026-06-05
00840456215203JMUJMU DENTAL, INCFRG2026-06-05
00840456216804JMUJMU DENTAL, INCFRG2026-06-05
00840456216811JMUJMU DENTAL, INCFRG2026-06-05
00840456216828JMUJMU DENTAL, INCFRG2026-06-05