ECG

GUDID 05099169413337

BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE

VITALOGRAPH (IRELAND) LIMITED

Electrocardiograph, professional, multichannel
Primary Device ID05099169413337
NIH Device Record Keyb29628d2-9c5d-402d-8657-2b627ed966d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG
Version Model Number4130
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
GS105099169413337 [Package]
Contains: 15099169413334
Package: [1 Units]
In Commercial Distribution
GS115099169413334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-19
Device Publish Date2021-07-09

On-Brand Devices [ECG]

05099169413030BT-12 ECG USA
05099169413337BT12 ECG AHA WITH SPIROTRAC 6 SOFTWARE
05099169413306BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE

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