Pneumotrac

GUDID 05099169777576

6800 PNEUMOTRAC HARDWARE ONLY US

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer
Primary Device ID05099169777576
NIH Device Record Key4ff36283-6ce6-416c-ae26-a7ab1d226a16
Commercial Distribution StatusIn Commercial Distribution
Brand NamePneumotrac
Version Model Number6800
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169777576 [Package]
Contains: 15099169777573
Package: [1 Units]
In Commercial Distribution
GS115099169777573 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-26
Device Publish Date2021-04-16

On-Brand Devices [Pneumotrac]

05099169777330MODEL 6800 INTRAC(1)
05099169777019MODEL 6800 PNEUMOTRAC US(1)
050991697700106800 PNEUMOTRAC USA
050991697775216800 PNEUMOTRAC -C(1)
050991697773236800 PNEUMOTRAC HARDWARE ONLY(1)
050991697705226800 PNEUMOTRAC-C(1)
050991697705086800 PNEUMOTRAC (HARDWARE ONLY)(1)
050991697775766800 PNEUMOTRAC HARDWARE ONLY US
050991697790206800 PNEUMOTRAC
050991697797236800 PNEUMOTRAC
050991697797786800 PNEUMOTRAC RMS (H/W ONLY)
050991697795706800 PNEUMOTRAC (H/W ONLY)

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