AIME 1776

GUDID 00850025200011

Disposable 3-ply earloop procedure mask

AIME USA LLC

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

• Primary Device ID: 00850025200011
• NIH Device Record Key: 08668d4d-2c68-4576-b855-a9c4d1460e51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIME 1776
• Version Model Number: GFM12
• Company DUNS: 117707985
• Company Name: AIME USA LLC
• Device Count: 1
• 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: true
• 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: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com
• Phone: 430-264-3872
• Email: support@aimeusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025200004 [Primary]
GS1	00850025200011 [Package]; Contains: 00850025200004; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123787

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: 2020-12-01
• Device Publish Date: 2020-11-23

On-Brand Devices [AIME 1776]

• 10850025200025: Disposable 3-ply earloop procedure mask
• 00850025200011: Disposable 3-ply earloop procedure mask