Regard

GUDID 00683534090343

A3PMSKUL4-REG AAMI Level 3, Procedure Mask, Earloop, Non Sterile, Universal Size, 50 Pcs/Dispenser

A PLUS INTERNATIONAL INC.

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

• Primary Device ID: 00683534090343
• NIH Device Record Key: 4c88d636-2ca2-4759-aac7-f0868ecac66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regard
• Version Model Number: A3PMSKUL4-REG
• Company DUNS: 191705904
• Company Name: A PLUS INTERNATIONAL 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: false
• Manufacturing Date: true
• 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	00683534090336 [Primary]
GS1	00683534090343 [Package]; Contains: 00683534090336; Package: Dispenser [50 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: 2025-08-14
• Device Publish Date: 2025-08-06

Devices Manufactured by A PLUS INTERNATIONAL INC.

• 00683534090343 - Regard: 2025-08-14A3PMSKUL4-REG AAMI Level 3, Procedure Mask, Earloop, Non Sterile, Universal Size, 50 Pcs/Dispenser
• 00683534090343 - Regard: 2025-08-14 A3PMSKUL4-REG AAMI Level 3, Procedure Mask, Earloop, Non Sterile, Universal Size, 50 Pcs/Dispenser
• 80683534080616 - A Plus: 2024-07-25 SetUpCovr44x78 1760/GL;2.25mil,N-S,fan,N STL
• 80683534040016 - A Plus: 2024-01-26 3M Hot Cold Pack - Nylon Cover, Bulk, 1000 PCS/CS
• 80683534040023 - A Plus: 2024-01-26 3M Hot Cold Pack - Spunbond Polypropylene Cover (Tri-Fold), Bulk, 2000 PCS/CS
• 80683534040030 - A Plus: 2024-01-26 3M Hot Cold Pack - #1572 Spunbond Polypropylene Cover, 100/CS
• 00683534090282 - A Plus: 2023-08-14 Procedure Mask Earloop Green ASTM Level 1
• 00683534090305 - A Plus: 2023-08-14 Procedure Mask Earloop Green ASTM Level 3
• 00683534090329 - A Plus: 2023-08-14 Surgical Mask Tie-on Blue ASTM Level 3