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

• 00781311701212 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, xl, 40 pk
• 00781311701229 - Raptor Grip: 2025-07-07 disposable gloves, powder-free, nitrile, blue, lg, 100 pk
• 00781311701236 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, xl, 100 pk
• 00781311701243 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, 2xl
• 00781311701250 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, md, 40 pk
• 00781311701267 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, lg, 40 pk
• 00781311701274 - Raptor Grip: 2025-07-07 disposable nitrile gloves, powder-free, blue, xl, 40 pk
• 00781311701298 - Raptor Grip: 2025-07-07 disposable nitrile glove, powder-free, blue, sm/md, 4 pk