FDA.reportPublic FDA data

CareGUARD

Primary DI
19332017001687
Brand
CareGUARD
Company
CARE ESSENTIALS PTY LTD
Model
SW919150-B/B
Catalog number
SW919150-B/B
Device description
CareGUARD Dual Layers, 91cm x 91cm (36" x 36"), 50GSM, Blue/blue
Published
2022-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213907000CareGUARD Sterilization WrapCare Essentials Pty, Ltd.2022-03-14FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19332017001687PackageGS150In Commercial Distribution
09332017001680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1933201700168719332017001687
09332017001680093320170016809332017001680

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
745058946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
09332017001451CareGUARDSW10010050-B/BSW10010050-B/B2022-04-06
09332017001468CareGUARDSW10010060-B/BSW10010060-B/B2022-04-06
09332017001475CareGUARDSW10010060-BSW10010060-B2022-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456202982JMUJMU DENTAL, INCFRG2026-06-05
00840456202999JMUJMU DENTAL, INCFRG2026-06-05
00840456207208JMUJMU DENTAL, INCFRG2026-06-05
00840456207215JMUJMU DENTAL, INCFRG2026-06-05
00840456215180JMUJMU DENTAL, INCFRG2026-06-05
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