Precept ®

GUDID 20814707022685

FluidGard® 160 Anti-Fog Procedure Mask

PRECEPT MEDICAL PRODUCTS, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20814707022685
• NIH Device Record Key: aeb69405-0436-4ad1-bfb0-d4bb8c816fb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precept ®
• Version Model Number: 14401
• Company DUNS: 783912892
• Company Name: PRECEPT MEDICAL PRODUCTS, 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: 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: 800-438-5827
• Email: customerservice@preceptmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814707022681 [Unit of Use]
GS1	10814707022688 [Primary]
GS1	20814707022685 [Package]; Contains: 10814707022688; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K771409

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-01-31

On-Brand Devices [Precept ® ]

• 20814707022753: Procedure Mask
• 20814707022692: Lite & Cool Surgical Mask with Anti-Glare Shield
• 20814707022685: FluidGard® 160 Anti-Fog Procedure Mask
• 20814707022661: FluidGard® 160 Anti-Fog Surgical Mask
• 10814707021254: Fluidgard® 160 Anti-Fog Surgical Mask with Anti-Glare Shield
• 20814707021244: FluidGard® 160 Anti-Fog Procedure Mask with Anti-Glare Shield
• 20814707020001: FLUIDGARD ® 160 ANTI-FOG PROCEDURE MASK WITH EXTENDED SHIELD