1MED

GUDID 00850039859489

1MED Surgical Mask, Level 2, Earloop style non-sterile, single-use, 50ct Box

Qyk Brands LLC

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: 00850039859489
• NIH Device Record Key: 17aef041-9d8a-4b29-92a6-a3c319189bb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1MED
• Version Model Number: 1MED-23LSM1
• Company DUNS: 081560441
• Company Name: Qyk Brands LLC
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850039859465 [Primary]
GS1	00850039859489 [Unit of Use]
GS1	10850039859462 [Package]; Contains: 00850039859465; Package: Case [20 Units]; In Commercial Distribution

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: 2022-05-09
• Device Publish Date: 2022-05-01

On-Brand Devices [1MED]

• 10850027748846: 1MED Disposable Surgical Gown, Large, sterile
• 00850039859496: 1MED Surgical Mask, Level 1, Earloop style non-sterile, single-use, 50ct Box
• 00850039859472: 1MED Surgical Mask, Level 3, Earloop style non-sterile, single-use, 50ct Box
• 00850039859489: 1MED Surgical Mask, Level 2, Earloop style non-sterile, single-use, 50ct Box