Spirotrac

GUDID 15099169676760

68674 software

VITALOGRAPH (IRELAND) LIMITED

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• Primary Device ID: 15099169676760
• NIH Device Record Key: a0dd213a-f7f4-4f0e-8eab-e0d6545b6df0
• 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	05099169706019 [Package]; Contains: 15099169676715; Package: [1 Units]; In Commercial Distribution
GS1	05099169706026 [Package]; Contains: 15099169676722; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706040 [Package]; Contains: 15099169676746; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706057 [Package]; Contains: 15099169676753; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706064 [Package]; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706071 [Package]; Contains: 15099169676777; Package: [1 Units]; In Commercial Distribution
GS1	05099169706118 [Package]; Contains: 15099169676814; Package: [1 Units]; In Commercial Distribution
GS1	05099169706125 [Package]; Contains: 15099169676821; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706156 [Package]; Contains: 15099169676852; Package: [1 Units]; Discontinued: 2017-01-26; Not in Commercial Distribution
GS1	05099169706194 [Package]; Contains: 15099169676890; Package: [1 Units]; In Commercial Distribution
GS1	15099169676715 [Package]; Contains: 65099169686740; Package: [15 Units]; In Commercial Distribution
GS1	15099169676722 [Package]; Contains: 65099169686740; Package: [15 Units]; Not in Commercial Distribution
GS1	15099169676746 [Package]; Contains: 65099169686740; Package: [15 Units]; Not in Commercial Distribution
GS1	15099169676753 [Package]; Contains: 65099169686740; Package: [15 Units]; Not in Commercial Distribution
GS1	15099169676760 [Package]; Contains: 65099169686740; Package: [15 Units]; Not in Commercial Distribution
GS1	15099169676777 [Package]; Contains: 65099169686740; Package: [15 Units]; In Commercial Distribution
GS1	15099169676814 [Package]; Contains: 65099169686740; Package: [15 Units]; In Commercial Distribution
GS1	15099169676821 [Package]; Contains: 65099169686740; Package: [15 Units]; Not in Commercial Distribution
GS1	15099169676852 [Package]; Contains: 65099169686740; Package: [15 Units]; In Commercial Distribution
GS1	15099169676890 [Package]; Contains: 65099169686740; Package: [15 Units]; In Commercial Distribution
GS1	65099169686740 [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