NASOMETER

GUDID 04961333247301

NASOMETER SOFTWARE

PENTAX OF AMERICA, INC.

Speech assistive training device
Primary Device ID04961333247301
NIH Device Record Keye0b267d3-8db6-4790-99a1-4c8ec2af7434
Commercial Distribution StatusIn Commercial Distribution
Brand NameNASOMETER
Version Model Number6500
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333247301 [Primary]

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-17
Device Publish Date2019-06-07

On-Brand Devices [NASOMETER]

04961333247318NASOMETER
04961333247301NASOMETER SOFTWARE

Trademark Results [NASOMETER]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NASOMETER
NASOMETER
98045631 not registered Live/Pending
Kahn, Sandra
2023-06-16

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