All Pro

GUDID 10016659570150

N95 mask, 20 masks per box, 12 boxes per master case

Bunzl USA Holdings LLC

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

• Primary Device ID: 10016659570150
• NIH Device Record Key: 8b27ff2f-1929-4c16-b908-8f1831dc9613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All Pro
• Version Model Number: 8610A
• Company DUNS: 799540588
• Company Name: Bunzl USA Holdings 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: 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	10016659570150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061375

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: 2025-04-14
• Device Publish Date: 2025-04-04

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