SAS Safety / Gerson

GUDID 00781311086104

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: 00781311086104
• NIH Device Record Key: 6a7c6b0c-b536-4e28-9a33-70e844dd86a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAS Safety / Gerson
• Version Model Number: 8610
• 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	00781311086104 [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

Devices Manufactured by Bunzl USA Holdings LLC

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• 00781311701045 - FINISHMASTER: 2025-04-28 disposable nitrile gloves, black, powder-free, 100 pack, medium
• 00781311701052 - FINISHMASTER: 2025-04-28 disposable nitrile gloves, black, powder-free, 100 pack, large
• 00781311701069 - FINISHMASTER: 2025-04-28 disposable nitrile gloves, black, powder-free, 100 pack, extra-large
• 00781311701076 - FINISHMASTER: 2025-04-28 disposable nitrile gloves, black, powder-free, 100 pack, extra-extra large
• 00781311005174 - Astro Grip: 2025-04-14 disposable nitrile gloves, powder-free, orange, 6 pk
• 00781311005181 - ASTRO GRIP: 2025-04-14 disposable nitrile gloves, powder-free, orange, 6pk
• 00781311086104 - SAS Safety / Gerson: 2025-04-14N95 mask, 20 masks per box, 12 boxes per master case
• 00781311086104 - SAS Safety / Gerson: 2025-04-14 N95 mask, 20 masks per box, 12 boxes per master case