Model 4000

GUDID 05099169404038

4000 RESPIRATORY MONITOR ASMA-1 USB GERMAN WITH REPORTS

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, electronic

• Primary Device ID: 05099169404038
• NIH Device Record Key: 26cb64e1-ab3f-4633-8a13-468483c97fa6
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169404038 [Package]; Contains: 15099169404035; Package: [1 Units]; In Commercial Distribution
GS1	15099169404035 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-08

On-Brand Devices [Model 4000]

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• 05099169403604: 4000 RESPIRATORY MONITOR ASMA-1 BT (1)
• 05099169403598: 4000 RESPIRATORY MONITOR LUNG MONITOR BT - 2NET
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