Precept®

GUDID 20814707020421

COMFORT-PLUS™ SURGICAL MASK

PRECEPT MEDICAL PRODUCTS, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20814707020421
• NIH Device Record Key: 205f41d6-aa63-46ba-88ac-25f905dfabe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precept®
• Version Model Number: 65 3120
• 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: 8004385827
• Email: customerservice@preceptmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814707020427 [Unit of Use]
GS1	10814707020424 [Primary]
GS1	20814707020421 [Package]; Contains: 10814707020424; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K770463

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: 2016-08-05

On-Brand Devices [Precept®]

• 00814707020700: Patient Welcome Kit
• 20814707020568: FATHERS KIT
• 20814707023095: Blue Film Gown with Thumb Loop
• 20814707022715: Blue Film Gown with Thumb Loop
• 20814707022654: Chemotherapy Gown with Knit Cuffs
• 20814707022364: Isolation Gown
• 20814707022227: Blue Film Gown
• 20814707022210: Blue Film Gown
• 20814707022104: Shoe Cover - Non-Conductive
• 20814707022098: Safe-T-Tread Shoe Cover - Non-Conductive
• 20814707022081: Safe-T-Tread Shoe Cover - Non-Conductive
• 20814707022074: Shoe Cover - Non-Conductive
• 20814707022050: Safe-T-Tread Shoe Cover - Non-Conductive
• 20814707021756: 3/4 Sleeve Patient Gown
• 20814707021732: Isolation Gown with Knit Cuffs
• 20814707021725: Isolation Gown with Knit Cuffs
• 20814707021718: Isolation Gown with Knit Cuffs
• 20814707021701: Isolation Gown with Elastic Cuffs
• 20814707021695: Bootcovers
• 20814707021688: Bootcovers
• 20814707021480: Isolation Gown with Elastic Cuffs
• 20814707021473: Patient Robe
• 20814707021466: Cover Gown with Open Back
• 20814707021459: Protective Sleeves
• 20814707021442: Patient Gown with Attached Belt
• 20814707021435: Patient Gown with Detached Belt
• 20814707021428: Patient Gown with Attached Belt
• 20814707021411: Patient Gown with Detached Belt
• 20814707021404: Patient Gown with Detached Belt
• 20814707021398: Patient Gown with Detached Belt
• 20814707021381: Patient Gown - No Belt
• 20814707021374: Patient Gown - No Belt
• 20814707021367: Patient Gown
• 20814707021350: Patient Gown
• 20814707021343: Isolation Gown with Knit Cuffs
• 20814707021336: Isolation Gown with Knit Cuffs
• 20814707021091: Exam Cape
• 20814707021084: Protective Sleeve
• 20814707021077: Cysto Apron
• 20814707021053: Legionnaire Surgical Hood with Tape Tab Closure
• 20814707021022: Full-face Pullover Cleanroom Hood with Ties
• 20814707021015: Full-face Cleanroom Hood with Snap Closure
• 20814707020971: Nonwoven Shoe Covers
• 20814707020964: 20" Cleanroom Boot Covers with Embossed Poly Sole
• 20814707020957: 20" Cleanroom Boot Covers with Embossed Poly Sole
• 20814707020940: Cleanroom Shoe Covers with Embossed Poly Sole
• 20814707020933: Cleanroom Shoe Covers with Embossed Poly Sole
• 20814707020841: Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back
• 20814707020810: Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back
• 20814707020735: Isolation Gown with Cuffs