FDA.reportPublic FDA data

BPR Medical

Primary DI
25060274504238
Brand
BPR Medical
Company
BPR MEDICAL LIMITED
Model
Firesafe Cannula Valve - Bidirectional Mk.2
Catalog number
827-2001
Device description
Firesafe Cannula Valve - Bidirectional Mk.2. 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
true

Contact Domains#

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
25060274504238PackageGS120In Commercial Distribution
35060274504235PackageGS1100In Commercial Distribution
05060274504234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2506027450423825060274504238
3506027450423535060274504235
05060274504234050602745042345060274504234

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

Contacts#

Phone, Email table
PhoneEmail
+441623628281cs@bprmedical.com

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
25060274502852BPR MedicalFiresafe Nozzle - DISS827-00302023-06-07
05060274504067BPR MedicalRange E - 0.01 - 1 lpm - Ohmeda/Barb816-00372023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628101624248OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624385OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624392OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624408OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101624415OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629236OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629243OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629250OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629922OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101629939OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630379OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630386OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630454OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630461OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101630683OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631093OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631109OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631116OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631123OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631130OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631147OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631154OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631161OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631178OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631185OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631192OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631208OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631215OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631222OhioOHIO MEDICAL, LLCCAX2026-10-22
00628101631239OhioOHIO MEDICAL, LLCCAX2026-10-22