SPIROTRAC

GUDID 05099169688001

7000 SPIROTRAC

VITALOGRAPH (IRELAND) LIMITED

Cardiopulmonary parameter spot-check measurement software

• Primary Device ID: 05099169688001
• NIH Device Record Key: 57d7f0d5-d820-4e4e-a541-d46c0fdebcdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIROTRAC
• Version Model Number: 7000
• 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: true
• 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	05099169688001 [Package]; Contains: 65099169688003; Package: [1 Units]; In Commercial Distribution
GS1	65099169688003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141546

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2021-04-30

On-Brand Devices [SPIROTRAC]

• 05099169706101: 68680 software
• 15099169676739: 68679 software
• 05099169706088: 68675 software
• 15099169676760: 68674 software
• 05099169688001: 7000 SPIROTRAC