OTOPod By Auditdata

GUDID 05711781001654

Auditdata A/S

Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester
Primary Device ID05711781001654
NIH Device Record Key339af2f1-347b-4e1f-9a79-6b26bbb5ad1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOTOPod By Auditdata
Version Model NumberOTOPod M2
Company DUNS310385849
Company NameAuditdata A/S
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS105711781001654 [Primary]

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-24

On-Brand Devices [OTOPod By Auditdata]

05711781001654OTOPod M2
05711781001647OTOPod M1

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