ProGear

GUDID 20852212003232

Imprints™ Customer Selected Custom Print, Tie (USA)

PRESTIGE AMERITECH, LTD.

Surgical/medical face mask, single-use

• Primary Device ID: 20852212003232
• NIH Device Record Key: 98e8af89-bd97-4934-b8ce-b55de08286f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGear
• Version Model Number: FM85120
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 50
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003238 [Primary]
GS1	20852212003232 [Package]; Contains: 00852212003238; Package: Case [6 Units]; In Commercial Distribution
GS1	80852212003234 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-26

On-Brand Devices [ProGear]

• 10852212003396: FM83130 ProGear Skin-Saver Ultra Mask Tie, Anti fog foam strip,White (USA)
• 10852212003389: FM83120 ProGear Skin-Saver Ultra Sensitive Tie-On, White
• 10852212003372: FM85121-CCM1 ProGear® Imprints-Cook Children's Medical Tie on Mask
• 00852212003368: FM85020 ProGear™ Mask, Isolation, Ear loop, Imprints™
• 10852212003341: Imprints™ Earloop Economy (USA)
• 10852212003327: ProGear™ N95 Surgical Mask Respirator, Regular, Fluid Resistant 160mm, Whit
• 10852212003310: ProGear™ N95 Surgical Mask Respirator, Small, Fluid Resistant 160mm, White
• 10852212003242: Ported N95 Particulate Filter Respirator
• 20852212003232: Imprints™ Customer Selected Custom Print, Tie (USA)
• 20852212003201: Imprints™ Customer Selected Custom Print Mask, Earloop (USA)
• 20852212003195: Pro-80™ Fluid Resistant Surgical Mask 80mm, Tie, Blue (USA)
• 20852212003188: Pro-80™ Fluid Resistant Procedure Mask 80mm, Earloop, Blue (USA)
• 20852212003171: Skin-Saver™ Sensitive Skin Mask, Tie, White (USA)
• 20852212003164: Skin-Saver™ Sensitive Skin Mask, Earloop, White (USA)
• 20852212003157: Dry Shield™ Fluid Resistant Mask 160mm, Tie, Anti-Glare/Anti-Fog Visor, Ice
• 20852212003140: Dry Shield™ Fluid Resistant Mask 160mm, Tie w/o Visor, Ice Blue (USA)
• 20852212003133: Dry Shield™ Fluid Resistant Mask 160mm, Earloop, Anti-Glare/Anti-Fog Visor,
• 20852212003126: Dry Shield™ Fluid Resistant Mask 160mm, Earloop w/o Visor, Ice Blue (USA)
• 20852212003119: Pro-Lite™ Surgical Mask, Tie, Blue (USA)
• 10852212003105: ProGear™ Isolation Mask, Earloop, Green (USA)
• 20852212003096: ProGear™ Procedure Mask, Earloop, Blue (USA)
• 00852212003085: ProGear™ Isolation Mask, Earloop, Yellow, Economy (USA)
• 20852212003072: Clear-View™ Anti-Fog Foam Strip Mask, Tie, Green (USA)
• 00852212003061: Pro-80™ Duckbill Fluid Resistant Mask 80mm, Tie, Anti-Glare/Anti-Fog Visor,
• 10852212003051: Pro-80™ Duckbill Fluid Resistant Mask 80mm, Tie, Blue (USA)
• 20852212003041: Pro-80™ Horizontal Tie, Fluid Resistant Mask 80mm, Anti-Glare/Anti-Fog Viso
• 30852212003031: Pro-80™ Horizontal Tie, Fluid Resistant Mask 80mm, Blue (USA)
• 20852212003027: Clear-View™ Anti-Fog Tape Strip Mask, Tie, Green (USA)
• 20852212003010: ProGear™ Isolation Mask, Earloop, Yellow (USA)
• 00852212003009: Clear-View™ Anti-Fog Film Strip Mask, Tie, Green (USA)
• 10852212003563: Dry Shield Fluid Resistant Personal Protection Gown
• 10852212003549: Face Shield, Full with 11" Drape, Foam Top, Elastic Headband
• 10852212003518: I-Gard
• 10852212003501: Face Shield with Headlight Flap, Foam Top, Elastic Headband
• 10852212003495: Clear-View Surgical Face Mask with Clear Window
• 10852212003594: Pink Pre-Assembled Glasses
• 00852212003573: Earloop Mask with Ribbon Print
• 20852212003584: Dry Shield TM Fluid Resistant Mask 160 mm, Tie w/o Visor, Blue
• 20852212003539: Dry Shield TM Fluid Resistant Mask 160mm, Earloop w/o Visor, Blue
• 20852212003645: Purple Striped Earloop Mask, bulk.
• 20852212003638: Extra Large Disposable Lenses
• 20852212003621: Seal-A-Mask Perimeter Seal Attachment for Masks
• 20852212003706: Metal-Free Mask, Earloop, Lawn Tan
• 10852212003297: PROGEAR® FULL FACE-SHIELD
• 10852212003679: Clear-View Surgical face Mask with Clear Window, ASTM Level 3
• 80852212003685: N95 Surgical Mask Respirator with Comfort Strip, Regluar
• 80852212003418: FM86000 Communicator Mask
• 10852212003693: N95 Surgical Mask Respirator with Comfort Strip, Small
• 20852212003744: Dry Shield, ASTM Level 3, Anti-Fog Film Strip Mask, Blue