FDA.reportPublic FDA data

Amvex Flowmeter

Primary DI
08592346997769
Brand
Amvex Flowmeter
Company
GCE, s.r.o.
Model
FA-15UA-DH
Catalog number
FLOWMETER 0-15 L/MIN USA AIR DISS HT
Device description
Flow devices are intended for the administration of the following medical gases in the treatment and care of patients. This flow selector is intended to be fitted to medical gas pipeline system terminal units in hospitals or ambulance cars or to a quick connector outlet of a medical gas regulator.
Published
2026-07-07
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
08592346997769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592346997769085923469977698592346997769

GMDN Terms#

Term, Definition table
TermDefinition
Medical gas flowmeter, Thorpe tubeA device intended to measure and 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 consists of an upright tube containing a float, which rises and falls in relation to gas flow, and a distal valve (compensated flowmeter) to control gas flow rate; some types include a pressure gauge/regulator. 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.

Regulatory Flags#

DUNS number
819753190
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
08592346652187Amvex FlowmeterFA-03IO-F2FLOWMETER 0-3 L/MIN ISO OXY 1/8" FNPT2026-07-07
08592346652194Amvex FlowmeterFA-03IO-DNFLOWMETER 0-3 L/MIN ISO OXY DISS NUT2026-07-07
08592346652200Amvex FlowmeterFA-03UO-F2FLOWMETER 0-3 L/MIN USA OXY 1/8" FNPT2026-07-07
08592346652217Amvex FlowmeterFA-03UO-DNFLOWMETER 0-3 L/MIN USA OXY DISS NUT2026-07-07
08592346652224Amvex FlowmeterFA-15IO-F2FLOWMETER 0-15 L/MIN ISO OXY 1/8" FNPT2026-07-07
08592346692329Amvex FlowmeterFA-15IO-DNFLOWMETER 0-15 L/MIN ISO OXY DISS NUT2026-07-07
08592346692404Amvex FlowmeterFA-15UO-F2FLOWMETER 0-15 L/MIN USA OXY 1/8" FNPT2026-07-07
08592346692442Amvex FlowmeterFA-15UO-DNFLOWMETER 0-15 L/MIN USA OXY DISS NUT2026-07-07
08592346692466Amvex FlowmeterFA-15IO-F2PTFLOWMETER 0-15 L/MIN ISO OXY 1/8" FNPT PTO2026-07-07
08592346692503Amvex FlowmeterFA-15IO-DNPTFLOWMETER 0-15 L/MIN ISO OXY DISS NUT PTO2026-07-07
08592346696914Amvex FlowmeterFA-15UO-F2PTFLOWMETER 0-15 L/MIN USA OXY 1/8" FNPT PTO2026-07-07
08592346705302Amvex FlowmeterFA-15UO-DNPTFLOWMETER 0-15 L/MIN USA OXY DISS NUT PTO2026-07-07
08592346732926Amvex FlowmeterFA-15IA-F2FLOWMETER 0-15 L/MIN ISO AIR 1/8" FNPT2026-07-07
08592346782013Amvex FlowmeterFA-15IA-DNFLOWMETER 0-15 L/MIN ISO AIR DISS NUT2026-07-07
08592346782020Amvex FlowmeterFA-15UA-F2FLOWMETER 0-15 L/MIN USA AIR 1/8" FNPT2026-07-07
08592346782075Amvex FlowmeterFA-15UA-DNFLOWMETER 0-15 L/MIN USA AIR DISS NUT2026-07-07
08592346782655Amvex FlowmeterFA-15IA-F2PTFLOWMETER 0-15 L/MIN ISO AIR 1/8" FNPT PTO2026-07-07
08592346782723Amvex FlowmeterFA-15IA-CHPTFLOWMETER 0-15 L/MIN ISO AIR CHEM PTO2026-07-07
08592346782730Amvex FlowmeterFA-15IA-DNPTFLOWMETER 0-15 L/MIN ISO AIR DISS NUT PTO2026-07-07
08592346815858Amvex FlowmeterFA-15IA-DHPTFLOWMETER 0-15 L/MIN ISO AIR DISS HT PTO2026-07-07

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
08592346652200Amvex FlowmeterGCE, s.r.o.CAX2026-07-07
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
08592346997776Amvex FlowmeterGCE, s.r.o.CAX2026-07-07