FDA.reportPublic FDA data

M9264-PCD-200, Pressure Tube

Primary DI
06420099001124
Brand
M9264-PCD-200, Pressure Tube
Company
Medikro Oy
Model
M9264-PCD-200
Published
2019-11-29
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06420099001124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06420099001124064200990011246420099001124

GMDN Terms#

Term, Definition table
TermDefinition
Spirometry/pulmonary function pressure tubeA non-sterile plastic tube intended to conduct airflow pressure from a breathing mouthpiece to a parent device (e.g., spirometer) during pulmonary function testing (e.g., respiratory gas volume and flow). It is intended to function with a separate spirometry device and/or a pulmonary function analyser and is not intended to be integrated into a breathing circuit during respiration. A tube holder may be included as an accessory device. This is a reusable device intended to be cleaned/disinfected prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
369263660
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732094130348703554 Spirometer Kit (USB)M94682026-04-21
06420099000042M921, Medikro® SpiroStar DXM94702026-04-21
06420099000219703552 Spirometer Kit (Serial)M94712026-04-21
06420099000264M9242-100, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000318703419 Disposable Flow Transducer QTY 100M9242-WA2026-04-21
06420099000325703418 Disposable Flow Transducer QTY 25M9242-WA2026-04-21
06420099000332703417 Disposable Flow Transducer QTY 4M9242-WA2026-04-21
06420099000448M929, Medikro® SpiroStar USBM94792026-04-21
06420099000622M9242-SP-90, SpiroSafe Disposable Flow TransducerM92422026-04-21
06420099000554M9256, SpiroSafe Disposable Flow TransducerM9256-1002018-07-13
06420099000677M9227, Nose ClipM92272018-07-13
06420099001117M9256-PCD, Disposable Flow Transducer, 100 pcsM9256-PCD-1002019-11-29
06420099000561M9256, SpiroSafe Disposable Flow TransducerM9256-SP-902018-07-13
06420099000691M91227-25, Medikro® GripM912272018-07-13
06420099000820M913, Medikro® NanoM94872018-07-13
06420099000837M915, Medikro® ProM94882018-07-13
06420099000851M914, Medikro® PrimoM94922018-07-13
06420099001094M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099001087M915-PCD, PCD Spirometer KitM9488-PCD2019-11-29
06420099000387M9474, Medikro® Calibration Syringe, 3000 mlM94742018-07-13

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