Spirotrac

GUDID 05099169706088

68675 software

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer

• Primary Device ID: 05099169706088
• NIH Device Record Key: 2c8450d3-7e2d-4274-a8ca-35a7919b5f9c
• 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	05099169706088 [Package]; Contains: 15099169676784; Package: [1 Units]; In Commercial Distribution
GS1	05099169706095 [Package]; Contains: 15099169676791; Package: [1 Units]; In Commercial Distribution
GS1	05099169706118 [Package]; Contains: 15099169676814; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	15099169676784 [Package]; Contains: 65099169686757; Package: [15 Units]; In Commercial Distribution
GS1	15099169676791 [Package]; Contains: 65099169686757; Package: [15 Units]; In Commercial Distribution
GS1	15099169676814 [Package]; Contains: 65099169686757; Package: [15 Units]; In Commercial Distribution
GS1	65099169686757 [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