FDA.reportPublic FDA data

BPR Medical

Primary DI
25060274502852
Brand
BPR Medical
Company
BPR MEDICAL LIMITED
Model
Firesafe Nozzle - DISS
Catalog number
827-0030
Device description
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.
Published
2023-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAXFlowmeter, Tube, Thorpe, Back-Pressure CompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
25060274502852PackageGS120In Commercial Distribution
05060274502858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2506027450285225060274502852
05060274502858050602745028585060274502858

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen tubing fire safety valveA safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
236040130
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05060274502414BPR MedicalNitric Oxide Regulator - CGA 626814-00042023-06-07
25060274502692BPR MedicalExhalation valve828-00032023-06-07
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
08592346652187Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652194Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
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08592346652217Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346652224Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692329Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692404Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692442Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692466Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346692503Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346696914Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346705302Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346732926Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782013Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782020Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782075Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782655Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782723Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346782730Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346815858Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893153Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893160Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893177Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893184Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893191Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346893207Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905603Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346905665Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997752Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
08592346997769Amvex FlowmeterGCE, s.r.o.CAX2026-07-07