FDA.reportPublic FDA data

CITREX H5

Primary DI
07640214642417
Brand
CITREX H5
Company
IMT Analytics AG
Model
304.555.000
Device description
Flowmeter, calibration, gas
Published
2022-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BXYFlowmeter, Calibration, Gas

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXYFlowmeter, Calibration, GasAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640214642165PackageGS11In Commercial Distribution
07640214642417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640214642165076402146421657640214642165
07640214642417076402146424177640214642417

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia/respiratory gas flowmeter testerA device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Regulatory Flags#

DUNS number
480035934
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640214642837FlowMeter F1700.400.0012023-09-18
07640214642844FlowMeter F2700.400.0022023-09-18
07640214642851FlowMeter F1700.400.0012023-09-18
07640214642868FlowMeter F2700.400.0022023-09-18
07640214642400CITREX H4302.161.0002022-11-17
07640214642448Flow Analyzer PF-300300.116.0002022-11-17
07640214642455Flow Analyzer PF-301300.116.0012022-11-17
07640214642462Flow Analyzer PF-302300.116.0022022-11-17
07640214642707Flow Analyzer PF-300 PRO700.300.0002022-11-17
07640214642363Smart Lung 2000 2 Liter302.730.1002022-11-17
07640214642370Smart Lung Adult 1 Liter300.162.1002022-11-17
07640214642387Smart Lung Infant 0.5 Liter300.400.1042022-11-17
07640214642394CITREX H3304.333.0002022-11-17
07640214641946CITREX H4302.161.0002022-11-17
07640214642165CITREX H5304.555.0002022-11-17
07640214641243Flow Analyzer PF-300300.116.0002022-11-17
07640214641250Flow Analyzer PF-301300.116.0012022-11-17
07640214641267Flow Analyzer PF-302300.116.0022022-11-17
07640214642691Easy Lung 1 Liter300.756.1002022-11-17
07640214642714Flow Analyzer PF-300 PRO700.300.0002022-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530108656Repair PartsSUNSET HEALTHCARE SOLUTIONS, INC.BXY2026-03-17
00850027043845Precision Medical Inc.Precision Medical, Inc.BXY2026-02-25
00848530105204REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
00848530105501REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
20848530105208REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
10848530105508REPAIR PARTSSUNSET HEALTHCARE SOLUTIONS, INC.BXY2025-08-27
00026072022443EMAllied Medical, LLCBXY2024-09-16
00026072022450EMAllied Medical, LLCBXY2024-09-16
00026072022467EMAllied Medical, LLCBXY2024-09-16
00026072022474EMAllied Medical, LLCBXY2024-09-16
00026072022481EMAllied Medical, LLCBXY2024-09-16
B366U1RH1011R-FLOWMETEREclerisBXY2024-08-16
00817770025863ManifoldMAXTEC, LLCBXY2024-08-14
00817770025870ManifoldMAXTEC, LLCBXY2024-08-14
00817770025955ManifoldMAXTEC, LLCBXY2024-08-14
00848530020019CPAP AccesorySUNSET HEALTHCARE SOLUTIONS, INC.BXY2024-06-17
00026072022511EMAllied Medical, LLCBXY2024-05-28
07640214642837FlowMeter F1IMT Analytics AGBXY2023-09-18
07640214642844FlowMeter F2IMT Analytics AGBXY2023-09-18
07640214642851FlowMeter F1IMT Analytics AGBXY2023-09-18
07640214642868FlowMeter F2IMT Analytics AGBXY2023-09-18
00851440007599Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007605Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00851440007612Responsive Respiratory, Inc.RESPONSIVE RESPIRATORY, INC.BXY2023-06-12
00817770022442BlenderBuddyMAXTEC, LLCBXY2023-06-08
00817770025726FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025733FlowmeterMAXTEC, LLCBXY2023-06-08
00817770025740FlowmeterMAXTEC, LLCBXY2023-06-08
07640214642400CITREX H4IMT Analytics AGBXY2022-11-17
07640214642448Flow Analyzer PF-300IMT Analytics AGBXY2022-11-17