FDA.reportPublic FDA data

PC

Primary DI
00026072017296
Brand
PC
Company
Allied Medical, LLC
Model
15002-03Y
Device description
"FLWMTR O2 CHEMTN QC 15LPM ""Y"""
Published
2023-12-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00026072017296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00026072017296000260720172960260720172960026072017296

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119066872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00026072021439PC11-20-00112024-09-17
00026072026861ALLIED MEDICAL LLC01-90-310001-90-31002025-10-13
00026072026878ALLIED MEDICAL LLC01-90-3100-KIT01-90-3100-KIT2025-10-13
00026072026892ALLIED MEDICAL LLC01-90-392801-90-39282025-10-13
00026072026908ALLIED MEDICAL LLC01-90-3928-KIT 01-90-3928-KIT 2025-10-13
00026072001479EMLPEEP2024-05-28
00026072012161BF645502024-05-28
00026072020548BF64095-AHP2024-10-11
00026072022177EML599-0102024-05-28
00026072022184EML599-0302024-05-28
00026072022191EML599-1302024-05-28
00026072022207EML599-1402024-05-28
00026072022214EML599-1802024-05-28
00026072022238EML599-1902024-05-28
00026072022252EML599-2802024-05-28
00026072022924BF338002024-10-11
00026072022931BF338012024-05-28
00026072023006BF332072024-10-11
00026072023013BF640072024-10-11
00026072023037BF640412024-05-28

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
08592346997769Amvex FlowmeterGCE, s.r.o.CAX2026-07-07