Altor Safety

GUDID G023622222Z2

Altor Safety 3-Ply Surgical Mask (Model:62222) Outer Case of 2,000 Masks

Altor Safety LLC

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

• Primary Device ID: G023622222Z2
• NIH Device Record Key: 389e37a1-7f1a-49e7-8c6a-4a2b0b648271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Altor Safety
• Version Model Number: 62222
• Company DUNS: 131388023
• Company Name: Altor Safety LLC
• Device Count: 2
• 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: false
• Serial Number: false
• 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

Customer Support Contacts

• Phone: (845) 422-8230
• Email: sales@altorsafety.com
• Phone: (845) 422-8230
• Email: sales@altorsafety.com
• Phone: (845) 422-8230
• Email: sales@altorsafety.com
• Phone: (845) 422-8230
• Email: sales@altorsafety.com
• Phone: (845) 422-8230
• Email: sales@altorsafety.com
• Phone: (845) 422-8230
• Email: sales@altorsafety.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity
• Special Storage Condition, Specify: Between 0 and 0 *Store at room tempature with low humitity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G023622222 [Primary]
HIBCC	G023622222Z2 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211249

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: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Altor Safety]

• G023622321Z2: Altor Safety 4-Ply Surgical Mask (Model:62232) Outer Case of 2,000 Masks
• G023622320: Altor Safety 4-Ply Surgical Mask (Model:62232) Inner Carton of 50 Masks
• G023622222Z2: Altor Safety 3-Ply Surgical Mask (Model:62222) Outer Case of 2,000 Masks
• G023622221: Altor Safety 3-Ply Surgical Mask (Model:62222) Inner Carton of 50 Masks