FDA.reportPublic FDA data

BPR Medical

Primary DI
05060274502414
Brand
BPR Medical
Company
BPR MEDICAL LIMITED
Model
Nitric Oxide Regulator - CGA 626
Catalog number
814-0004
Device description
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.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CANRegulator, Pressure, Gas Cylinder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060274502414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060274502414050602745024145060274502414

GMDN Terms#

Term, Definition table
TermDefinition
Fixed medical gas cylinder regulatorA gas-regulating component of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure. It typically includes a cylinder shut-off switch (i.e., cylinder valve), regulator controls, manometer(s), a refill port, and a safety relief valve to avoid excessive pressure due to increased ambient temperatures. It is intended to be permanently fitted by a manufacturer to the stem of a valveless (i.e., open) empty medical gas cylinder prior to filling.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401623628281cs@bprmedical.com

Regulatory Flags#

DUNS number
236040130
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060274504357BPR MedicalRange A 0.02 - 3 l/min - DISS/Barb816-00482024-10-01
05060274504364BPR MedicalRange A 0.02 - 3 l/min - DISS/Barb816-00492024-10-01
05060274504371BPR MedicalRange E 0.01 - 1 l/min - DISS/Barb816-00502024-10-01
05060274504388BPR MedicalRange E 0.01 - 1 l/min - DISS/DISS816-00512024-10-01
05060274502698BPR MedicalExhalation valve828-00032023-06-07
05060274502858BPR MedicalFiresafe Nozzle - DISS827-00302023-06-07
05060274504234BPR MedicalFiresafe Cannula Valve - Bidirectional Mk.2827-20012023-06-07
05060274500687BPR MedicalOxygen demand valve 3m hose DISS831-50032023-06-07
05060274501257BPR MedicalRange A 0.02 - 3 l/min - DISS/Barb816-00322023-06-07
05060274501264BPR MedicalRange A 0.02 - 3 l/min - DISS/DISS816-00332023-06-07
05060274501271BPR MedicalRange E 0.01 - 1 l/min - DISS/Barb816-00342023-06-07
05060274501288BPR MedicalRange E 0.01 - 1 l/min - DISS/DISS816-00352023-06-07
25060274502692BPR MedicalExhalation valve828-00032023-06-07
25060274502852BPR MedicalFiresafe Nozzle - DISS827-00302023-06-07
05060274504067BPR MedicalRange E - 0.01 - 1 lpm - Ohmeda/Barb816-00372023-06-07
25060274504238BPR MedicalFiresafe Cannula Valve - Bidirectional Mk.2827-20012023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101620387OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620837OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101620851OhioOHIO MEDICAL, LLCCAN2026-05-18
00628101632625OhioOHIO MEDICAL, LLCCAN2026-05-18
00819601025837EscalonAirgas Therapeutics, LLCCAN2025-11-21
30653405988636Beamer AVEOConmed CorporationCAN2024-12-31
00810050863025MEDPAKLIFEPORT, LLCCAN2024-12-02
G298153187300010NAControl Devices, LLCCAN2024-08-09
G2983429110200B080NAControl Devices, LLCCAN2024-08-09
G2981531871600100NAControl Devices, LLCCAN2024-08-08
G298153187160050NAControl Devices, LLCCAN2024-08-08
G298153187270020NAControl Devices, LLCCAN2024-08-08
G298153187270040NAControl Devices, LLCCAN2024-08-08
G298153187270050NAControl Devices, LLCCAN2024-08-08
G298153187270080NAControl Devices, LLCCAN2024-08-08
G298153187280010NAControl Devices, LLCCAN2024-08-08
G298153187280020NAControl Devices, LLCCAN2024-08-08
G298153187280030NAControl Devices, LLCCAN2024-08-08
G298153187280040NAControl Devices, LLCCAN2024-08-08
G2982108080NAControl Devices, LLCCAN2024-08-08
G2982108150NAControl Devices, LLCCAN2024-08-08
G2982108250NAControl Devices, LLCCAN2024-08-08
G2982212200NAControl Devices, LLCCAN2024-08-08
G2982216200NAControl Devices, LLCCAN2024-08-08
G2982217200NAControl Devices, LLCCAN2024-08-08
G298153187280050NAControl Devices, LLCCAN2024-07-30
G298153187280080NAControl Devices, LLCCAN2024-07-30
G298202230NAControl Devices, LLCCAN2024-07-30
G298153187220010NAControl Devices, LLCCAN2024-07-26
G298153187220020NAControl Devices, LLCCAN2024-07-26