Communicator

GUDID 10852212003662

Surgical Facemask with Clear Window, ASTM Level 3

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 10852212003662
• NIH Device Record Key: 7aaf25a9-19c0-4e68-8007-017c36e53742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Communicator
• Version Model Number: FM86001
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 40
• 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: false
• 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: false

Customer Support Contacts

• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com
• Phone: 18664018972
• Email: orders@prestigeam.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003665 [Primary]
GS1	10852212003662 [Package]; Contains: 00852212003665; Package: Case [10 Units]; In Commercial Distribution
GS1	80852212003661 [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: 2022-10-07
• Device Publish Date: 2022-09-29

Devices Manufactured by PRESTIGE AMERITECH, LTD.

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• 80852212003418 - ProGear: 2023-08-16 FM86000 Communicator Mask
• 80852212003685 - ProGear: 2022-10-24 N95 Surgical Mask Respirator with Comfort Strip, Regluar
• 10852212003662 - Communicator: 2022-10-07Surgical Facemask with Clear Window, ASTM Level 3
• 10852212003662 - Communicator: 2022-10-07 Surgical Facemask with Clear Window, ASTM Level 3
• 10852212003679 - ProGear: 2022-10-07 Clear-View Surgical face Mask with Clear Window, ASTM Level 3
• 10852212003297 - ProGear: 2022-09-16 PROGEAR® FULL FACE-SHIELD
• 20852212003706 - ProGear: 2022-08-29 Metal-Free Mask, Earloop, Lawn Tan
• 20852212003621 - ProGear: 2022-06-10 Seal-A-Mask Perimeter Seal Attachment for Masks