MYCO MYEL 30000

GUDID 20386120010865

Facemask, ASTM Level 3, Earloop

MYCO MEDICAL SUPPLIES INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20386120010865
• NIH Device Record Key: 1229008f-67b6-42b4-9a25-3da61125e770
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYCO
• Version Model Number: MYEL 30000
• Catalog Number: MYEL 30000
• Company DUNS: 879187821
• Company Name: MYCO MEDICAL SUPPLIES INC.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386120010861 [Unit of Use]
GS1	10386120010868 [Primary]
GS1	20386120010865 [Package]; Contains: 10386120010868; Package: Case [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160269

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: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-04-24

On-Brand Devices [MYCO]

• 20386120010889: Facemask, ASTM Level 3, Tie-On
• 20386120010865: Facemask, ASTM Level 3, Earloop
• 20386120010858: Facemask, N95 Particulate Respirator, Small
• 20386120010841: Facemask, N95 Particulate Respirator, Medium
• 20386120010933: Facemask, ASTM Level 2, Earloop