Opti-Gard D28300CE

GUDID 00850017419049

Opti-Gard LARGE CE NON-STERILE PACK

DUPACO, INC.

Eye splash shield, single-use

• Primary Device ID: 00850017419049
• NIH Device Record Key: 0d2f9c5d-45c1-4164-9066-567d3e85ce67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opti-Gard
• Version Model Number: D28300CE
• Catalog Number: D28300CE
• Company DUNS: 093616555
• Company Name: DUPACO, INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com
• Phone: +1(760)758-4550
• Email: dly@dupacoinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017419049 [Unit of Use]
GS1	10850017419046 [Primary]

FDA Product Code

• HOY: Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

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: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [Opti-Gard]

• 00850017419339: Opti-Gard LARGE CE NON-STERILE PACK, BRAZIL
• 00850017419322: Opti-Gard SMALL CE NON-STERILE PACK, BRAZIL
• 10850017419091: CHIN UP FLEXIBLE ARM
• 00850017419087: CHIN UP FOAM END PACK
• 00850017419070: LASER OPTI-GARD LARGE NON-STERILE PACK
• 00850017419063: Opti-Gard LARGE STERILE PACK
• 00850017419056: Opti-Gard DOUBLE FOAM NON-STERILE PACK
• 00850017419049: Opti-Gard LARGE CE NON-STERILE PACK
• 00850017419032: Opti-Gard SMALL CE NON-STERILE PACK