Leader

GUDID 00715912137385

Leader 5ct N95 Masks

Shepard Medical Products, Inc.

Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 00715912137385
• NIH Device Record Key: fce17364-0a61-41ce-9256-8e7f8289a61a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leader
• Version Model Number: 5512934
• Company DUNS: 609079769
• Company Name: Shepard Medical Products, Inc.
• Device Count: 24
• 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: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com
• Phone: 630-539-7790
• Email: info@shepard-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00715912137385 [Unit of Use]
GS1	10096295137382 [Primary]

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: 2023-09-13
• Device Publish Date: 2023-01-06

On-Brand Devices [Leader]

• 00715912137385: Leader 5ct N95 Masks
• 00715912122299: Leader 20ct Earloop Masks