Model 4000

GUDID 35099169400659

4000 RESPIRATORY MONITOR ASMA-1 CHILD

VITALOGRAPH (IRELAND) LIMITED

Peak flow meter, electronic

• Primary Device ID: 35099169400659
• NIH Device Record Key: f22d44d1-da4d-449f-abe1-4fd7c2510641
• 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: true
• 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 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
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099169400658 [Package]; Contains: 15099169400655; Package: [1 Units]; In Commercial Distribution
GS1	15099169400655 [Primary]
GS1	35099169400659 [Package]; Contains: 05099169400658; 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: 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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• 05099169407503: 4000 RESPIRATORY MONITOR LUNG MONITOR BT INT
• 35099169407498: 4000 RESPIRATORY MONITOR LUNG MONITOR USB
• 05099169407480: 4000 RESPIRATORY MONITOR LUNG MONITOR USB (BASIC PACK)
• 35099169407306: 4000 RESP LUNG MONITOR USB - MED (BULK PACK)
• 05099169407039: 4000 RESPIRATORY MONITOR LUNG MON. USB GERMAN WITH REPORTS
• 05099169407008: 4000 RESPIRATORY MONITOR LUNG MONITOR USB INT.
• 35099169405500: 4000 RESPIRATORY MONITOR LUNG MONITOR
• 05099169405035: 4000 RESPIRATORY MONITOR LUNG AGE GERMAN
• 35099169405012: 4000 RESPIRATORY MONITOR LUNG AGE US
• 05099169405004: 4000 RESPIRATORY MONITOR LUNG AGE
• 05099169404991: 4000 RESPIRATORY MONITOR COPD-6 USB
• 05099169404984: 4000 RESPIRATORY MONITOR COPD-6 USB (BASIC PACK)
• 05099169404601: nmd-1 USB SANTHERA
• 05099169404595: 4000 RESPIRATORY MONITOR COPD-6 USB KOREAN
• 05099169404533: 4000 RESPIRATORY MONITOR COPD-6 USB GERMAN WITH REPORTS
• 05099169404519: 4000 RESPIRATORY MONITOR COPD-6 USB US
• 05099169404502: 4000 RESPIRATORY MONITOR COPD-6 USB INT.
• 05099169404496: 4000 RESPIRATORY MONITOR ASMA-1
• 35099169404480: 4000 RESPIRATORY MONITOR ASMA-1 USB
• 05099169404472: 4000 RESPIRATORY MONITOR ASMA-1 USB (BASIC PACK)
• 05099169404465: 4000 RESPIRATORY MONITOR ASMA-1 USB STANDARD-ALL TESTS SAVED
• 05099169404038: 4000 RESPIRATORY MONITOR ASMA-1 USB GERMAN WITH REPORTS
• 05099169404007: 4000 RESPIRATORY MONITOR ASMA-1 USB INT.
• 05099169403789: 4000 RESPIRATORY MONITOR LUNG MONITOR BT IC (1)
• 05099169403734: MODEL 4000 RESP. MON. LUNG MONITOR BT SMART (BULK)
• 05099169403727: MODEL 4000 RESPIRATORY MONITOR LUNG MONITOR BT SMART INTL
• 05099169403703: 4000 RESPIRATORY MONITOR COPD-6 BT (BASIC PACK)
• 05099169403642: 4000 RESPIRATORY MONITOR COPD-6 BT KOREAN
• 35099169403636: 4000 RESPIRATORY MONITOR LUNG MONITOR BT - 2Net (BULK PACK)
• 35099169403629: 4000 RESPIRATORY MONITOR COPD-6 BT - 2Net (BULK PACK)
• 05099169403611: 4000 RESPIRATORY MONITOR ASMA-1 BT - 2Net (BULK PACK)
• 05099169403604: 4000 RESPIRATORY MONITOR ASMA-1 BT (1)
• 05099169403598: 4000 RESPIRATORY MONITOR LUNG MONITOR BT - 2NET
• 05099169403581: 4000 RESPIRATORY MONITOR COPD-6 BT - 2NET
• 05099169403574: 4000 RESPIRATORY MONITOR ASMA-1 BT - 2NET
• 05099169403550: 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN
• 05099169403543: 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN - HEALTH INSIGHT
• 05099169403536: 4000 RESPIRATORY MONITOR COPD-6 BT GERMAN WITH REPORTS
• 05099169403505: 4000 RESPIRATORY MONITOR COPD-6 BT INT
• 05099169403482: 4000 RESPIRATORY MONITOR ASMA-1 BT (1)
• 35099169403476: 4000 RESPIRATORY MONITOR ASMA-1 BT (1)
• 35099169403469: 4000 RESPIRATORY MONITOR ASMA-1 BT (1)
• 05099169403208: 4000 RESPIRATORY MONITOR ASMA-1 BT (BASIC PACK)
• 05099169403031: 4000 RESPIRATORY MONITOR ASMA-1 BT GERMAN WITH REPORTS
• 05099169403000: 4000 RESPIRATORY MONITOR ASMA-1 BT INT
• 35099169402912: 4000 RESPIRATORY MONITOR COPD-6
• 35099169402905: 4000 RESPIRATORY MONITOR RC CHECK COPD-6