Medical Face Mask

GUDID 04007418891158

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Hans Hepp GmbH & Co. KG

Public face mask, single-use

• Primary Device ID: 04007418891158
• NIH Device Record Key: d6c02538-f5a6-44ed-b308-f5259c7f524b
• Commercial Distribution Discontinuation: 2023-07-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Medical Face Mask
• Version Model Number: 89115
• Company DUNS: 315896217
• Company Name: Hans Hepp GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	04007418891158 [Primary]

FDA Product Code

• QKR: Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

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: 2023-08-07
• Device Publish Date: 2023-07-28

On-Brand Devices [Medical Face Mask]

• 04007418891158: A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of t
• 04007418891141: A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of t