Barrier 42311

GUDID 07323190000647

Mölnlycke Health Care AB

Surgical/medical face mask, single-use

• Primary Device ID: 07323190000647
• NIH Device Record Key: b15ed9ab-ece0-47e5-8e4b-349cc78b4e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Barrier
• Version Model Number: 42311-01
• Catalog Number: 42311
• Company DUNS: 631770658
• Company Name: Mölnlycke Health Care AB
• Device Count: 60
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07323190000647 [Package]; Contains: 07323190000654; Package: [10 Units]; In Commercial Distribution
GS1	07323190000654 [Primary]
GS1	07332430952486 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K920108

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: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Barrier]

• 07332430617644: 4272-00
• 07332430617606: 4273-00
• 07332430085078: 4270-00
• 07332430084804: 4235-00
• 07323190046058: 42291-01
• 07323190045990: 42281-01
• 07323190045938: 4225-01
• 07323190045907: 42241-01
• 07323190045181: 42371-02
• 07323190045150: 42331-02
• 07323190043330: 42671-01
• 07323190043279: 42321-01
• 07323190001118: 42391-02
• 07323190000913: 42381-01
• 07323190000760: 42341-01
• 07323190000647: 42311-01
• 07323190000586: 42301-01
• 07323190000524: 42361-01