BPR Medical 814-0004

GUDID 05060274502414

The Nitric Oxide Pressure Regulator is intended to be used as a component part in a wider medical system for the controlled delivery of nitric oxide gas in dilute form for patients with respiratory disease.

BPR MEDICAL LIMITED

Fixed medical gas cylinder regulator
Primary Device ID05060274502414
NIH Device Record Key6fc6a838-60c6-48f0-843d-7b175f44f26f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBPR Medical
Version Model NumberNitric Oxide Regulator - CGA 626
Catalog Number814-0004
Company DUNS236040130
Company NameBPR MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com
Phone+4401623628281
Emailcs@bprmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060274502414 [Primary]

FDA Product Code

CANRegulator, Pressure, Gas Cylinder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

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

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