Practicon Bliss™ Level 3 Face Mask 50/Box Black 7158246 BLA

GUDID 00723896029886

Soft level 3 face mask with extra soft ear loops for comfort. 50 per box

PRACTICON, INC.

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 00723896029886
• NIH Device Record Key: afd980d8-a130-4bf6-b9fc-8ebdaed1e986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Practicon Bliss™ Level 3 Face Mask 50/Box Black
• Version Model Number: 7158246 BLA
• Catalog Number: 7158246 BLA
• Company DUNS: 119193803
• Company Name: PRACTICON, 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00723896029879 [Primary]
GS1	00723896029886 [Package]; Contains: 00723896029879; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222697

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: 2026-01-16
• Device Publish Date: 2026-01-08

Devices Manufactured by PRACTICON, INC.

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• 00723896029886 - Practicon Bliss™ Level 3 Face Mask 50/Box Black: 2026-01-16Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
• 00723896029886 - Practicon Bliss™ Level 3 Face Mask 50/Box Black: 2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
• 00723896029916 - Practicon Bliss™ Level 3 Face Mask 50/Box Blue: 2026-01-16 Soft level 3 face mask with extra soft ear loops for comfort. 50 per box
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• 00723896030325 - ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030356 - ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030387 - ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag
• 00723896030417 - ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack: 2026-01-16 Single use impression trays used to take a impression of a patients mouth in a dental setting. 10 per bag