ECG

GUDID 05099169413306

BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE

VITALOGRAPH (IRELAND) LIMITED

Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel Electrocardiograph, professional, multichannel

• Primary Device ID: 05099169413306
• NIH Device Record Key: 8df80f14-d71b-4348-bbb9-fc546f58fb05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG
• Version Model Number: 4130
• Company DUNS: 219683489
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169413306 [Package]; Contains: 15099169413303; Package: [1 Units]; In Commercial Distribution
GS1	15099169413303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082077

FDA Product Code

• DXH: TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-19
• Device Publish Date: 2021-07-09

On-Brand Devices [ECG]

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