Spirotrac

GUDID 05099169706088

68675 software

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer
Primary Device ID05099169706088
NIH Device Record Key2c8450d3-7e2d-4274-a8ca-35a7919b5f9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpirotrac
Version Model Number7000
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169706088 [Package]
Contains: 15099169676784
Package: [1 Units]
In Commercial Distribution
GS105099169706095 [Package]
Contains: 15099169676791
Package: [1 Units]
In Commercial Distribution
GS105099169706118 [Package]
Contains: 15099169676814
Package: [1 Units]
Discontinued: 2017-01-26
Not in Commercial Distribution
GS115099169676784 [Package]
Contains: 65099169686757
Package: [15 Units]
In Commercial Distribution
GS115099169676791 [Package]
Contains: 65099169686757
Package: [15 Units]
In Commercial Distribution
GS115099169676814 [Package]
Contains: 65099169686757
Package: [15 Units]
In Commercial Distribution
GS165099169686757 [Primary]

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 Date2016-12-14

On-Brand Devices [Spirotrac]

0509916970610168680 software
1509916967673968679 software
0509916970608868675 software
1509916967676068674 software
050991696880017000 SPIROTRAC

Trademark Results [Spirotrac]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIROTRAC
SPIROTRAC
75228785 2215740 Live/Registered
Vitalograph Limited
1997-01-21
SPIROTRAC
SPIROTRAC
74474724 not registered Dead/Abandoned
Healthdyne Technologies, Inc.
1993-12-30

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