Model 4000

GUDID 35099169403797

4000 RESPIRATORY MONITOR ASMA-1 MANNKIND

VITALOGRAPH (IRELAND) LIMITED

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• Primary Device ID: 35099169403797
• NIH Device Record Key: 894c8a53-137b-4b4c-93f2-6f1d172798e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 4000
• Version Model Number: 4000
• 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	05099169403796 [Package]; Contains: 15099169403793; Package: [1 Units]; In Commercial Distribution
GS1	15099169403793 [Primary]
GS1	35099169403797 [Package]; Contains: 05099169403796; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073155

FDA Product Code

• BZG: SPIROMETER, DIAGNOSTIC

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: 2021-01-07
• Device Publish Date: 2020-12-30

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