Emergency Rescue Mask

GUDID B859ERM1010

It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

CBX LLC

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• Primary Device ID: B859ERM1010
• NIH Device Record Key: 67b4cc64-3e03-4c5d-b864-5e7787fcc1d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emergency Rescue Mask
• Version Model Number: ERM101
• Company DUNS: 110960383
• Company Name: CBX 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B859ERM1010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083418

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2020-02-24
• Device Publish Date: 2020-02-15

Devices Manufactured by CBX LLC

• B859FRK1021 - First Responder Kit: 2021-04-09 First Responder Kit contains CPR mask, one pair of nitrile gloves, emergency shears, safety prep razor, dry cleaning towel and N
• B859FRK10109 - First Responder Kit: 2020-03-27 First Responder Kit contains CPR Mask with oxygen port, one pair of nitrile gloves, emergency shears, safety prep razor, dry cle
• B859ERM1010 - Emergency Rescue Mask: 2020-02-24It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.
• B859ERM1010 - Emergency Rescue Mask: 2020-02-24 It is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.