BPR Medical

Basic Information

• Brand Name: BPR Medical
• Primary DI: 05060274502698
• Version / Model: Exhalation valve
• Catalog Number: 828-0003
• Company Name: BPR MEDICAL LIMITED
• Labeler DUNS: 236040130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-07
• Public Version: 1
• Public Version Date: 2023-06-15
• Public Version Status: New
• Public Device Record Key: 99c1c73f-c597-4c5d-8f57-6f2bb6ebac53

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17169	Demand valve	A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25060274502692	GS1	Carton	100	In Commercial Distribution
Primary	05060274502698	GS1

Premarket Submissions

Submission Number	Supplement Number
K082345	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius