BRS Level 3 Procedure Face Mask - 3 Layers BRS3561

GUDID 00850021617578

Level 3 Procedure Face Mask with Ear Loops - 3 Layers

Blackbriar Regulatory Services, LLC

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

• Primary Device ID: 00850021617578
• NIH Device Record Key: 89a0aaa1-c321-4681-a0a4-68b996dc05a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRS Level 3 Procedure Face Mask - 3 Layers
• Version Model Number: 850021617561
• Catalog Number: BRS3561
• Company DUNS: 117425172
• Company Name: Blackbriar Regulatory Services, LLC
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021617561 [Primary]
GS1	00850021617578 [Package]; Contains: 00850021617561; Package: Case [12 Units]; In Commercial Distribution

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: 2021-04-12
• Device Publish Date: 2021-04-02

Devices Manufactured by Blackbriar Regulatory Services, LLC

• 10850021617193 - BRS Level 2 Procedure Mask with Ear Loops: 2021-04-12 Level 2 Procedure Face Mask with Ear Loops
• 00850021617578 - BRS Level 3 Procedure Face Mask - 3 Layers: 2021-04-12Level 3 Procedure Face Mask with Ear Loops - 3 Layers
• 00850021617578 - BRS Level 3 Procedure Face Mask - 3 Layers: 2021-04-12 Level 3 Procedure Face Mask with Ear Loops - 3 Layers
• 10850021617001 - BRS Level 1 Procedure Face Mask with Ear Loops: 2021-04-06 Level 1 Procedure Face Mask with Ear Loops - Updated