Respiratory Shield

GUDID 00860008240118

Robrady Inc

Respirator filter/cartridge, particulates

• Primary Device ID: 00860008240118
• NIH Device Record Key: b9294f1f-44e3-428b-b5de-dc8a1f5ef73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Respiratory Shield
• Version Model Number: SFER-0S-1001
• Company DUNS: 064578649
• Company Name: Robrady Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00860008240118 [Primary]
GS1	00860008240149 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• LYU: Accessory, Surgical Apparel

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: 2022-02-17
• Device Publish Date: 2022-02-09

Devices Manufactured by Robrady Inc

• 00860008240101 - EndoShield: 2022-02-17
• 00860008240118 - Respiratory Shield: 2022-02-17
• 00860008240118 - Respiratory Shield: 2022-02-17
• 00860008240125 - Portable Negative Pressure Vacuum: 2022-02-17