AIM

GUDID 35099169457103

45710

VITALOGRAPH (IRELAND) LIMITED

Aerosol inhalation monitor
Primary Device ID35099169457103
NIH Device Record Keyf2ff0ddc-966d-4c0a-ba23-6d2d78b6c75e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIM
Version Model Number4500
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169457102 [Package]
Contains: 15099169457109
Package: [1 Units]
In Commercial Distribution
GS115099169457109 [Primary]
GS135099169457103 [Package]
Contains: 05099169457102
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BWFSPIROMETER, THERAPEUTIC (INCENTIVE)

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 Date2017-02-20

On-Brand Devices [AIM]

3509916945739445739
3509916945738745738
0509916945737945737
0509916945735545735
3509916945734945734
3509916945733245733
3509916945732545732
3509916945710345710
05099169331884Vitalograph AIM

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