Advance Plus™ Earloop Procedure Masks ADV2315

GUDID 20810012650025

Earloop Procedure Masks, ASTM Level 3, Pink, Box

SOUTHERN ANESTHESIA & SURGICAL, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20810012650025
• NIH Device Record Key: a3e2b74b-5285-4583-b7f2-ef13ebe56343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advance Plus™ Earloop Procedure Masks
• Version Model Number: ADV2315
• Catalog Number: ADV2315
• Company DUNS: 119186732
• Company Name: SOUTHERN ANESTHESIA & SURGICAL, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810012650021 [Unit of Use]
GS1	10810012650028 [Primary]
GS1	20810012650025 [Package]; Contains: 10810012650028; Package: case [10 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-03-10

On-Brand Devices [Advance Plus™ Earloop Procedure Masks]

• 20810012650032: Earloop Procedure Masks, ASTM Level 3, Blue, Box
• 20810012650025: Earloop Procedure Masks, ASTM Level 3, Pink, Box
• 20810012650018: Earloop Procedure Masks, ASTM Level 1, Blue, Box
• 20810012650001: Earloop Procedure Masks, ASTM Level 1, Pink, Box