VitaloJAK

GUDID 05099169715110

Base VITALOJAK

VITALOGRAPH (IRELAND) LIMITED

Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system Cough ambulatory recording system
Primary Device ID05099169715110
NIH Device Record Key242ac5ed-8130-47d3-8aec-91b9606e7c8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitaloJAK
Version Model Number7100
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
GS105099169715110 [Package]
Contains: 15099169715117
Package: [1 Units]
In Commercial Distribution
GS115099169715117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRECORDER, MAGNETIC TAPE, MEDICAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-28
Device Publish Date2021-06-18

On-Brand Devices [VitaloJAK]

05099169715103Base VITALOJAK INTERNATIONAL WEST(1)
05099169710238Base VITALOJAK - SHORT CABLE(1)
05099169710023Base VitaloJAK UK(1)
05099169715110Base VITALOJAK

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