Model 4000

GUDID 35099169402035

4000 RESPIRATORY MONITOR COPD-6 GERMANY

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, electronic
Primary Device ID35099169402035
NIH Device Record Key619ca0bc-0a8f-4b5b-9777-bd0ab12a2681
Commercial Distribution StatusIn Commercial Distribution
Brand NameModel 4000
Version Model Number4000
Company DUNS219683489
Company NameVITALOGRAPH (IRELAND) LIMITED
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169402034 [Package]
Contains: 15099169402031
Package: [1 Units]
In Commercial Distribution
GS115099169402031 [Primary]
GS135099169402035 [Package]
Contains: 05099169402034
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSPIROMETER, DIAGNOSTIC

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 Date2016-12-08

On-Brand Devices [Model 4000]

050991694079784000 RESPIRATORY MONITOR LUNG MONITOR BT
050991694077014000 RESPIRATORY MONITOR LUNG MONITOR BT (BASIC PACK)
050991694075344000 RESPIRATORY MONITOR LUNG MON. BT GERMAN WITH REPORTS
050991694075034000 RESPIRATORY MONITOR LUNG MONITOR BT INT
350991694074984000 RESPIRATORY MONITOR LUNG MONITOR USB
050991694074804000 RESPIRATORY MONITOR LUNG MONITOR USB (BASIC PACK)
350991694073064000 RESP LUNG MONITOR USB - MED (BULK PACK)
050991694070394000 RESPIRATORY MONITOR LUNG MON. USB GERMAN WITH REPORTS
050991694070084000 RESPIRATORY MONITOR LUNG MONITOR USB INT.
350991694055004000 RESPIRATORY MONITOR LUNG MONITOR
050991694050354000 RESPIRATORY MONITOR LUNG AGE GERMAN
350991694050124000 RESPIRATORY MONITOR LUNG AGE US
050991694050044000 RESPIRATORY MONITOR LUNG AGE
050991694049914000 RESPIRATORY MONITOR COPD-6 USB
050991694049844000 RESPIRATORY MONITOR COPD-6 USB (BASIC PACK)
05099169404601nmd-1 USB SANTHERA
050991694045954000 RESPIRATORY MONITOR COPD-6 USB KOREAN
050991694045334000 RESPIRATORY MONITOR COPD-6 USB GERMAN WITH REPORTS
050991694045194000 RESPIRATORY MONITOR COPD-6 USB US
050991694045024000 RESPIRATORY MONITOR COPD-6 USB INT.
050991694044964000 RESPIRATORY MONITOR ASMA-1
350991694044804000 RESPIRATORY MONITOR ASMA-1 USB
050991694044724000 RESPIRATORY MONITOR ASMA-1 USB (BASIC PACK)
050991694044654000 RESPIRATORY MONITOR ASMA-1 USB STANDARD-ALL TESTS SAVED
050991694040384000 RESPIRATORY MONITOR ASMA-1 USB GERMAN WITH REPORTS
050991694040074000 RESPIRATORY MONITOR ASMA-1 USB INT.
050991694037894000 RESPIRATORY MONITOR LUNG MONITOR BT IC (1)
05099169403734MODEL 4000 RESP. MON. LUNG MONITOR BT SMART (BULK)
05099169403727MODEL 4000 RESPIRATORY MONITOR LUNG MONITOR BT SMART INTL
050991694037034000 RESPIRATORY MONITOR COPD-6 BT (BASIC PACK)
050991694036424000 RESPIRATORY MONITOR COPD-6 BT KOREAN
350991694036364000 RESPIRATORY MONITOR LUNG MONITOR BT - 2Net (BULK PACK)
350991694036294000 RESPIRATORY MONITOR COPD-6 BT - 2Net (BULK PACK)
050991694036114000 RESPIRATORY MONITOR ASMA-1 BT - 2Net (BULK PACK)
050991694036044000 RESPIRATORY MONITOR ASMA-1 BT (1)
050991694035984000 RESPIRATORY MONITOR LUNG MONITOR BT - 2NET
050991694035814000 RESPIRATORY MONITOR COPD-6 BT - 2NET
050991694035744000 RESPIRATORY MONITOR ASMA-1 BT - 2NET
050991694035504000 RESPIRATORY MONITOR ASMA-1 BT GERMAN
050991694035434000 RESPIRATORY MONITOR ASMA-1 BT GERMAN - HEALTH INSIGHT
050991694035364000 RESPIRATORY MONITOR COPD-6 BT GERMAN WITH REPORTS
050991694035054000 RESPIRATORY MONITOR COPD-6 BT INT
050991694034824000 RESPIRATORY MONITOR ASMA-1 BT (1)
350991694034764000 RESPIRATORY MONITOR ASMA-1 BT (1)
350991694034694000 RESPIRATORY MONITOR ASMA-1 BT (1)
050991694032084000 RESPIRATORY MONITOR ASMA-1 BT (BASIC PACK)
050991694030314000 RESPIRATORY MONITOR ASMA-1 BT GERMAN WITH REPORTS
050991694030004000 RESPIRATORY MONITOR ASMA-1 BT INT
350991694029124000 RESPIRATORY MONITOR COPD-6
350991694029054000 RESPIRATORY MONITOR RC CHECK COPD-6

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