BPR Medical 827-0030

GUDID 25060274502852

Firesafe Nozzle - DISS. The intended medical purpose is to act as part of a conduit assembly through which oxygen is delivered to patients during normobaric oxygen therapy. A further non-medical purpose is to extinguish a fire in oxygen therapy tubing and isolate the oxygen supply. The non-medical purpose is further described in the technical description below.

BPR MEDICAL LIMITED

Oxygen tubing fire safety valve

• Primary Device ID: 25060274502852
• NIH Device Record Key: b45db06a-b0f7-4565-b568-d62d7e3048c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPR Medical
• Version Model Number: Firesafe Nozzle - DISS
• Catalog Number: 827-0030
• Company DUNS: 236040130
• Company Name: BPR MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	05060274502858 [Primary]
GS1	25060274502852 [Package]; Contains: 05060274502858; Package: Carton [20 Units]; In Commercial Distribution

FDA Product Code

• CAX: Flowmeter, Tube, Thorpe, Back-Pressure Compensated

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

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• 25060274502852: Firesafe Nozzle - DISS. The intended medical purpose is to act as part of a conduit assembly thr
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• 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