Advanced Concept Innovations (ACI)

GUDID 00860005493227

ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIOSH/FDA (TC-84A-9318), for use in healthcare settings. ACI’s Surgical N95 Respirator conforms to recognized standards for flammability, fluid resistance, and biocompatibility. Fluid resistance is a level 3, which is the highest level of protection (160 mm Hg).

Advanced Concept Innovations, LLC

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 00860005493227
• NIH Device Record Key: 70cb8f2e-d0c9-47c0-81d2-43f2f7d2b20d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Concept Innovations (ACI)
• Version Model Number: 3120
• Company DUNS: 191062566
• Company Name: Advanced Concept Innovations, LLC
• Device Count: 300
• DM Exempt: false
• Pre-market Exempt: true
• 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	00860005493203 [Unit of Use]
GS1	00860005493227 [Primary]

FDA Product Code

• MSH: Respirator, 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: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [Advanced Concept Innovations (ACI)]

• 00860005493227: ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIO
• 00860005493210: ACI’s Model 3120, light blue single use Surgical N95 Respirator is approved and cleared by NIO