SafeSource Direct Level 3 Surgical Mask with Ties

GUDID 00850037747139

Blue ASTM Level 3 Surgical Mask with Ties

Safesource Direct, L.L.C.

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 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: 00850037747139
• NIH Device Record Key: 40917ec1-ccac-4a39-a432-23af8a4909e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSource Direct Level 3 Surgical Mask with Ties
• Version Model Number: SM3003
• Company DUNS: 118070602
• Company Name: Safesource Direct, L.L.C.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com
• Phone: 3372107920
• Email: general@safesourcedirect.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850037747139 [Primary]
GS1	00850037747610 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221134

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: 2023-05-24
• Device Publish Date: 2023-05-16

Devices Manufactured by Safesource Direct, L.L.C.

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• 00850037747139 - SafeSource Direct Level 3 Surgical Mask with Ties: 2023-05-24Blue ASTM Level 3 Surgical Mask with Ties
• 00850037747139 - SafeSource Direct Level 3 Surgical Mask with Ties: 2023-05-24 Blue ASTM Level 3 Surgical Mask with Ties
• 00850037747146 - SafeSource Direct Level 1 Procedure Mask with Ear Loops: 2023-05-24 Blue ASTM Level 1 Procedure Mask with soft ear loops
• 00850037747153 - SafeSource Direct Level 3 Procedure Mask with Ear Loops: 2023-05-24 Blue ASTM Level 3 Procedure Mask with soft ear loops
• 00850037747269 - SafeSource Shoe Covers: 2023-05-24 Universal Blue Shoe Covers