EasyOne Pro LAB 3100-1

GUDID 07640142190370

NDD Medizintechnik AG

Pulmonary function analysis system, adult
Primary Device ID07640142190370
NIH Device Record Keye99a461c-32dc-4cac-a557-ed934cc573cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyOne Pro LAB
Version Model Number3100-1
Catalog Number3100-1
Company DUNS487451916
Company NameNDD Medizintechnik AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41444452530
Emailinfo@ndd.ch

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142190370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTYCalculator, Predicted Values, Pulmonary Function

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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07640142190516 - EasyOne FlowTube2023-06-30
07640142190462 - EasyOne FlowTube2023-06-30
07640142190561 - Filter Adapter SP2023-06-30
07640142190578 - Filter Adapter FT2023-06-30

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