Isofluid™ Earloop Mask

GUDID 10732224004362

Isofluid™ Earloop Mask

CROSSTEX INTERNATIONAL, INC.

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

• Primary Device ID: 10732224004362
• NIH Device Record Key: 76b4b2fa-a86a-4951-9259-940e3a935b75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isofluid™ Earloop Mask
• Version Model Number: GCIBL300
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 300
• 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: 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: true

Customer Support Contacts

• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE
• Special Storage Condition, Specify: Between 0 and 0 *FALSE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224004365 [Primary]
GS1	10732224004362 [Unit of Use]

FDA Product Code

• FXX: Mask, surgical

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: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [Isofluid™ Earloop Mask]

• 10732224004362: Isofluid™ Earloop Mask
• 00732224004365: Isofluid™ Earloop Mask