CareGUARD SW10010075-B/W

GUDID 19332017002080

CareGUARD Contrast, 100cm x 100cm (40" x 40"), 75GSM, Blue/white

CARE ESSENTIALS PTY LTD

Sterilization packaging, single-use

• Primary Device ID: 19332017002080
• NIH Device Record Key: ccead852-a27d-4510-9cdc-5db39a0a2e66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareGUARD
• Version Model Number: SW10010075-B/W
• Catalog Number: SW10010075-B/W
• Company DUNS: 745058946
• Company Name: CARE ESSENTIALS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au
• Phone: +61352771455
• Email: queries@careessentials.com.au

Device Identifiers

Device Issuing Agency	Device ID
GS1	09332017002083 [Primary]
GS1	19332017002080 [Package]; Contains: 09332017002083; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213907

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-14
• Device Publish Date: 2022-04-06

On-Brand Devices [CareGUARD]

• 19332017002202: CareGUARD Contrast, 137cm x 182cm (54" x 72"), 75GSM, Blue/white
• 19332017002196: CareGUARD Contrast, 137cm x 182cm (54" x 72"), 60GSM, Blue/white
• 19332017002097: CareGUARD Contrast, 60cm x 60cm (24" x 24"), 75GSM, Blue/white
• 19332017002080: CareGUARD Contrast, 100cm x 100cm (40" x 40"), 75GSM, Blue/white
• 19332017002073: CareGUARD Contrast, 120cm x 120cm (48" x 48"), 75GSM, Blue/white
• 19332017002066: CareGUARD Contrast, 60cm x 60cm (24" x 24"),60GSM, Blue/white
• 19332017002059: CareGUARD Contrast, 100cm x 100cm (40" x 40"), 60GSM, Blue/white
• 19332017002042: CareGUARD Contrast, 120cm x 120cm (48" x 48"), 60GSM, Blue/white
• 19332017002035: CareGUARD Contrast, 60cm x 60cm (24" x 24"), 50GSM, Blue/white
• 19332017002028: CareGUARD Contrast, 100cm x 100cm (40" x 40"), 50GSM, Blue/white
• 19332017002011: CareGUARD Contrast, 120cm x 120cm (48" x 48"), 50GSM, Blue/white
• 19332017001991: CareGUARD Contrast, 137cm x 182cm (54" x 72"), 50GSM, Blue/white
• 19332017001984: CareGUARD Dual Layers, 137cm x 182cm (54" x 72"), 75GSM, Blue/blue
• 19332017001977: CareGUARD Dual Layers, 137cm x 182cm (54" x 72"), 60GSM, Blue/blue
• 19332017001960: CareGUARD Dual Layers, 137cm x 182cm (54" x 72"), 50GSM, Blue/blue
• 19332017001953: CareGUARD Single Layer, 137cm x 182cm (54" x 72"), 75GSM, Blue
• 19332017001946: CareGUARD Single Layer, 137cm x 182cm (54" x 72"), 60GSM, Blue
• 19332017001939: CareGUARD Single Layer, 137cm x 182cm (54" x 72"), 50GSM, Blue
• 19332017001922: CareGUARD Contrast, 137cm x 137cm (54" x 54"), 75GSM, Blue/white
• 19332017001915: CareGUARD Contrast, 137cm x 137cm (54" x 54"), 60GSM, Blue/white
• 19332017001908: CareGUARD Contrast, 137cm x 137cm (54" x 54"), 50GSM, Blue/white
• 19332017001892: CareGUARD Dual Layers, 137cm x 137cm (54" x 54"), 75GSM, Blue/blue
• 19332017001885: CareGUARD Dual Layers, 137cm x 137cm (54" x 54"), 60GSM, Blue/blue
• 19332017001878: CareGUARD Dual Layers, 137cm x 137cm (54" x 54"), 50GSM, Blue/blue
• 19332017001861: CareGUARD Single Layer, 137cm x 137cm (54" x 54"), 75GSM, Blue
• 19332017001854: CareGUARD Single Layer, 137cm x 137cm (54" x 54"), 60GSM, Blue
• 19332017001847: CareGUARD Single Layer, 137cm x 137cm (54" x 54"), 50GSM, Blue
• 19332017001830: CareGUARD Contrast, 116cm x 116cm (45" x 45"), 75GSM, Blue/white
• 19332017001823: CareGUARD Contrast, 116cm x 116cm (45" x 45"), 60GSM, Blue/white
• 19332017001816: CareGUARD Contrast, 116cm x 116cm (45" x 45"), 50GSM, Blue/white
• 19332017001809: CareGUARD Dual Layers, 116cm x 116cm (45" x 45"), 75GSM, Blue/blue
• 19332017001793: CareGUARD Dual Layers, 116cm x 116cm (45" x 45"), 60GSM, Blue/blue
• 19332017001786: CareGUARD Dual Layers, 116cm x 116cm (45" x 45"), 50GSM, Blue/blue
• 19332017001779: CareGUARD Single Layer, 116cm x 116cm (45" x 45"), 75GSM, Blue
• 19332017001762: CareGUARD Single Layer, 116cm x 116cm (45" x 45"), 60GSM, Blue
• 19332017001755: CareGUARD Single Layer, 116cm x 116cm (45" x 45"), 50GSM, Blue
• 19332017001731: CareGUARD Contrast, 91cm x 91cm (36" x 36"), 75GSM, Blue/white
• 19332017001724: CareGUARD Contrast, 91cm x 91cm (36" x 36"), 60GSM, Blue/white
• 19332017001717: CareGUARD Contrast, 91cm x 91cm (36" x 36"), 50GSM, Blue/white
• 19332017001700: CareGUARD Dual Layers, 91cm x 91cm (36" x 36"), 75GSM, Blue/blue
• 19332017001694: CareGUARD Dual Layers, 91cm x 91cm (36" x 36"), 60GSM, Blue/blue
• 19332017001687: CareGUARD Dual Layers, 91cm x 91cm (36" x 36"), 50GSM, Blue/blue
• 19332017001670: CareGUARD Single Layer, 91cm x 91cm (36" x 36"), 75GSM, Blue
• 19332017001663: CareGUARD Single Layer, 91cm x 91cm (36" x 36"), 60GSM, Blue
• 19332017001656: CareGUARD Single Layer, 91cm x 91cm (36" x 36"), 50GSM, Blue
• 19332017001649: CareGUARD Dual Layers, 76cm x 76cm (30" x 30"), 75GSM, Blue/blue
• 19332017001632: CareGUARD Dual Layers, 76cm x 76cm (30" x 30"), 60GSM, Blue/blue
• 19332017001625: CareGUARD Dual Layers, 76cm x 76cm (30" x 30"), 50GSM, Blue/blue
• 19332017001618: CareGUARD Single Layer, 76cm x 76cm (30" x 30"), 75GSM, Blue
• 19332017001601: CareGUARD Single Layer, 76cm x 76cm (30" x 30"), 60GSM, Blue