Isofluid Surgical Masks GCIPWB

GUDID 30732224120233

With Fog Free Strip and Shield. ASTM Level 1, Blue

CROSSTEX INTERNATIONAL, INC.

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 30732224120233
• NIH Device Record Key: a9110ee6-ac56-4a85-a43b-c031d7f8bb67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isofluid Surgical Masks
• Version Model Number: GCIPWB
• Catalog Number: GCIPWB
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 25
• DM Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224120232 [Unit of Use]
GS1	10732224120239 [Primary]
GS1	30732224120233 [Package]; Contains: 10732224120239; Package: carton [4 Units]; In Commercial Distribution

FDA Product Code

• FXX: Mask, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2025-07-15
• Device Publish Date: 2016-11-11

Devices Manufactured by CROSSTEX INTERNATIONAL, INC.

• 10732224000050 - Crosstex International: 2025-07-25 (POUCH 5.25X10 SELFSEAL)
• 30732224120233 - Isofluid Surgical Masks: 2025-07-15With Fog Free Strip and Shield. ASTM Level 1, Blue
• 30732224120233 - Isofluid Surgical Masks: 2025-07-15 With Fog Free Strip and Shield. ASTM Level 1, Blue
• 50732224005008 - Safe-Flo Plus Saliva Ejector: 2024-12-02 White/White
• 50732224004988 - Safe-Flo Plus Saliva Ejector: 2024-12-02 Clear/White
• 50732224005015 - Safe-Flo Plus Saliva Ejector: 2024-12-02 White/Green, Mint Scented
• 50732224005022 - Safe-Flo Plus Saliva Ejector: 2024-12-02 White/Pink, Bubblegum Scented
• 00732224005508 - DentaPure 365-Day Independent Water Bottle Cartridge: 2024-09-16 Water Purification Bottle Cartridge
• 00732224005515 - DentaPure Water Purification Municipal Cartridge: 2024-09-16 Water Purification Municipal Cartridge