SPIROTRAC

GUDID 05099169688001

7000 SPIROTRAC

VITALOGRAPH (IRELAND) LIMITED

Cardiopulmonary parameter spot-check measurement software
Primary Device ID05099169688001
NIH Device Record Key57d7f0d5-d820-4e4e-a541-d46c0fdebcdd
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 Numbertrue
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
GS105099169688001 [Package]
Contains: 65099169688003
Package: [1 Units]
In Commercial Distribution
GS165099169688003 [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 Number2
Public Version Date2023-04-04
Device Publish Date2021-04-30

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.