ECG

GUDID 05099169413306

BT-12 ECG IEC with SPIROTRAC 6 SOFTWARE

VITALOGRAPH (IRELAND) LIMITED

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