Defender Safety Procedure Mask Level 1 DSM-PM01-B

GUDID 00860007209505

The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.

Defender Safety Inc.

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 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: 00860007209505
• NIH Device Record Key: 450343be-3eed-4cce-81f4-b331596d8825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Defender Safety Procedure Mask Level 1
• Version Model Number: DSM-PM01-B
• Catalog Number: DSM-PM01-B
• Company DUNS: 117018052
• Company Name: Defender Safety Inc.
• Device Count: 1
• 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: true
• 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: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com
• Phone: 18556433336
• Email: Nahal@defendersafety.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007209505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210705

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: 2021-07-16
• Device Publish Date: 2021-07-08

Devices Manufactured by Defender Safety Inc.

• 00860007209505 - Defender Safety Procedure Mask Level 1: 2021-07-16The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile.
• 00860007209505 - Defender Safety Procedure Mask Level 1: 2021-07-16 The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel fr
• 00860007209512 - Defender Safety Procedure Mask Level 2: 2021-07-16 The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel fr
• 00860007209529 - Defender Safety Procedure Mask Level 3: 2021-07-16 The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel fr
• 00860007209536 - Defender Safety Surgical Mask Level 3: 2021-07-16 The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel fr