BPR Medical 828-0003

GUDID 25060274502692

The exhalation valve is a single patient use disposable accessory for use with the oxygen demand valve

BPR MEDICAL LIMITED

Demand valve

• Primary Device ID: 25060274502692
• NIH Device Record Key: 99c1c73f-c597-4c5d-8f57-6f2bb6ebac53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPR Medical
• Version Model Number: Exhalation valve
• Catalog Number: 828-0003
• Company DUNS: 236040130
• Company Name: BPR MEDICAL LIMITED
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060274502698 [Primary]
GS1	25060274502692 [Package]; Contains: 05060274502698; Package: Carton [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082345

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: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [BPR Medical]

• 25060274504238: Firesafe Cannula Valve - Bidirectional Mk.2. The intended medical purpose is to act as part of a
• 05060274504067: Microdial Flowmeter - Range A 0.02 - 3 l/min - Ohmeda/Barb. Provides a controlled flow of medici
• 25060274502852: Firesafe Nozzle - DISS. The intended medical purpose is to act as part of a conduit assembly thr
• 25060274502692: The exhalation valve is a single patient use disposable accessory for use with the oxygen demand
• 05060274502414: The Nitric Oxide Pressure Regulator is intended to be used as a component part in a wider medica
• 05060274501288: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/DISS. Provides a controlled flow of medicina
• 05060274501271: Microdial Flowmeter - Range E 0.01 - 1 l/min - DISS/Barb. Provides a controlled flow of medicina
• 05060274501264: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/DISS. Provides a controlled flow of medicina
• 05060274501257: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/Barb. Provides a controlled flow of medicina
• 05060274500687: Oxygen demand valve. Used for the self-administration of oxygen by a spontaneously breathing pat
• 05060274504388: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/DISS (green). Provides a controlled flow of
• 05060274504371: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/Barb (green). Provides a controlled flow of
• 05060274504364: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/DISS (green). Provides a controlled flow of
• 05060274504357: Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/Barb (green). Provides a controlled flow of