VitaloJAK

GUDID 05099169710238

Base VITALOJAK - SHORT CABLE(1)

VITALOGRAPH (IRELAND) LIMITED

Cough ambulatory recording system Cough ambulatory recording system
Primary Device ID05099169710238
NIH Device Record Key55b03b57-608f-4e82-8a2f-fc90468059b7
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105099169710238 [Package]
Contains: 15099169710235
Package: [1 Units]
In Commercial Distribution
GS115099169710235 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-08
Device Publish Date2018-05-17

On-Brand Devices [VitaloJAK]

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

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