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

• 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
• 10016659570150 - All Pro: 2025-04-14 N95 mask, 20 masks per box, 12 boxes per master case
• 00781311700857 - SAS Safety Corp: 2025-02-10 First Aid Kit - 25 Person Kit - 200 Pieces - Contents 200 pieces: (1) SILVEX Wound Gel 0.18 oz (15) Alcohol Prep Pads (15) Antis
• 00781311700871 - SAS Safety Corp: 2025-02-10 First Aid Kit 100 Person Kit - Contents 358 pieces: (2) SILVEX Wound Gel 0.18 oz (24) Alcohol Prep Pads (24) Antiseptics Wipes (
• 00781311006256 - SAS: 2024-12-02 First Aid 25 Person Kit, OSHA ANSI 154 pcs. - (15) Alcohol Prep Pads; (12) Antiseptic Wipes; (1) Eye Wash 1.01 fl oz [30 ml]; (6
• 00781311006508 - SAS: 2024-12-02 First Aid 50 Person Kit, OSHA ANSI 223 pcs. - (2) SILVEX® Wound Gel 0.18 oz [5 g]; (6) Antibiotic Ointments 0.03 oz [0.90 g]; (