ProGear

GUDID 10852212003563

Dry Shield Fluid Resistant Personal Protection Gown

PRESTIGE AMERITECH, LTD.

Isolation gown, single-use

• Primary Device ID: 10852212003563
• NIH Device Record Key: 86a03018-8646-4119-9758-61898623e5d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProGear
• Version Model Number: GN22010
• Company DUNS: 199692794
• Company Name: PRESTIGE AMERITECH, LTD.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852212003566 [Primary]
GS1	10852212003563 [Package]; Contains: 00852212003566; Package: Case [1 Units]; In Commercial Distribution
GS1	80852212003562 [Unit of Use]

FDA Product Code

• FME: Gown, Examination

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: 2019-09-25
• Device Publish Date: 2019-09-17

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• 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)
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• 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
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• 20852212003133: Dry Shield™ Fluid Resistant Mask 160mm, Earloop, Anti-Glare/Anti-Fog Visor,
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• 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,
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• 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)
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• 10852212003594: Pink Pre-Assembled Glasses
• 00852212003573: Earloop Mask with Ribbon Print
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