DIMAR 700/7319US

GUDID 28056814676265

"DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XXL

HMC PREMEDICAL SPA

CPAP/BPAP face mask, single-use

• Primary Device ID: 28056814676265
• NIH Device Record Key: 0b7d6b30-1916-4a32-b4fd-aa4098d0c6f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIMAR
• Version Model Number: 700/7319US
• Catalog Number: 700/7319US
• Company DUNS: 339002025
• Company Name: HMC PREMEDICAL SPA
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it
• Phone: +39 053522704
• Email: giovanna.gavioli@hmcgroup.it

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056814676261 [Primary]
GS1	28056814676265 [Package]; Contains: 08056814676261; Package: carton box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232836

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [DIMAR]

• 28056814676401: "DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XXL
• 28056814676395: "DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XL
• 28056814676388: "DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE L
• 28056814676371: "DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE M
• 08056814676360: "DIMAX" TOTAL FACE MASK FOR NIV SINGLE USE SIZE S
• 28056814676265: "DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XXL
• 28056814676258: "DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE XL
• 28056814676241: "DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE L
• 08056814676230: "DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE M
• 28056814676227: "DIMAX ZERO" TOTAL FACE MASK FOR NIV SINGLE USE SIZE S