Spirotrac

GUDID 05099169706101

68680 software

VITALOGRAPH (IRELAND) LIMITED

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• Primary Device ID: 05099169706101
• NIH Device Record Key: 117de4c7-117a-4d05-b806-3427bf8e3f90
• 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: false
• 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	05099169706101 [Package]; Contains: 15099169676807; Package: [1 Units]; In Commercial Distribution
GS1	15099169676807 [Package]; Contains: 65099169686801; Package: [15 Units]; In Commercial Distribution
GS1	65099169686801 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-14

On-Brand Devices [Spirotrac]

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