COMPACT

GUDID 05099169678019

6600 COMPACT (FA)

VITALOGRAPH (IRELAND) LIMITED

Diagnostic spirometer

• Primary Device ID: 05099169678019
• NIH Device Record Key: 495380ec-319e-421d-ac05-9d76ebd16afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPACT
• Version Model Number: 6600
• 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: false
• 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	05099169678019 [Package]; Contains: 15099169678016; Package: [1 Units]; In Commercial Distribution
GS1	15099169678016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854526

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [COMPACT]

• 05099169414846: GENERIC CLINICAL TRIAL CASE - MIP MEP COMPACT(1)
• 05099169678019: 6600 COMPACT (FA)
• 05099169673038: 6600 COMPACT RMS
• 05099169673021: 6600 COMPACT