M9264-PCD-200, Pressure Tube

GUDID 06420099001124

Medikro Oy

Spirometry/pulmonary function pressure tube
Primary Device ID06420099001124
NIH Device Record Key27739628-6bd0-4c42-a044-6a7e079aebfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameM9264-PCD-200, Pressure Tube
Version Model NumberM9264-PCD-200
Company DUNS369263660
Company NameMedikro Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106420099001124 [Primary]

FDA Product Code

BYXTubing, Pressure And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-09
Device Publish Date2019-11-29

Devices Manufactured by Medikro Oy

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06420099000561 - M9256, SpiroSafe Disposable Flow Transducer2020-03-23
06420099001087 - M915-PCD, PCD Spirometer Kit2019-12-09
06420099001124 - M9264-PCD-200, Pressure Tube2019-12-09
06420099001124 - M9264-PCD-200, Pressure Tube2019-12-09
06420099000387 - M9474, Medikro® Calibration Syringe, 3000 ml2018-08-13
06420099000486 - M9264-200, Pressure Tube2018-08-13
06420099000677 - M9227, Nose Clip2018-08-13

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