FDA.reportPublic FDA data

BPR Medical

Primary DI
05060274504357
Brand
BPR Medical
Company
BPR MEDICAL LIMITED
Model
Range A 0.02 - 3 l/min - DISS/Barb
Catalog number
816-0048
Device description
Microdial Flowmeter - Range A 0.02 - 3 l/min - DISS/Barb (green). Provides a controlled flow of medicinal oxygen for the treatment of acute or chronic hypoxia.
Published
2024-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BYMTube, Thorpe, Uncompensated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYMTube, Thorpe, UncompensatedAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060274504357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060274504357050602745043575060274504357

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, dial-typeA device intended to regulate the flow of a medical gas [e.g., oxygen (O2), carbon dioxide (CO2), nitrous oxide (N2O), helium/oxygen gas mixture (heliox), medical air] during various procedures (e.g., therapeutic administration, anaesthesia, insufflation during surgery). It has a pre-calibrated adjustable flow selection dial intended to control the gas flow rate; it is not intended to provide flow rate measurements. It will be calibrated to a specific medical gas and have a dedicated flow rate range, therefore some types may be dedicated to a specific patient group (e.g., neonate, infant, adult) or clinical use.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
25060274504238BPR MedicalFiresafe Cannula Valve - Bidirectional Mk.2827-20012023-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060274504364BPR MedicalBPR MEDICAL LIMITEDBYM2024-10-01
05060274504371BPR MedicalBPR MEDICAL LIMITEDBYM2024-10-01
05060274504388BPR MedicalBPR MEDICAL LIMITEDBYM2024-10-01
00815277020985CuraplexBOUND TREE MEDICAL, LLCBYM2016-12-14
00026072000724Life Support Products (LSP)Allied Medical, LLCBYM2015-11-23
00260720000722Life Support Products (LSP)ALLIED HEALTHCARE PRODUCTS, INC.BYM2015-11-23