VADI G-328001-1-CFS

GUDID 14719894380893

Reusable ventilator circuit/ tubing (Without heated wire)

VADI MEDICAL TECHNOLOGY CO., LTD.

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• Primary Device ID: 14719894380893
• NIH Device Record Key: aa34fa76-eefc-4e97-a90d-3eab0c999027
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VADI
• Version Model Number: G-328001-1
• Catalog Number: G-328001-1-CFS
• Company DUNS: 657254280
• Company Name: VADI MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719894380896 [Primary]
GS1	14719894380893 [Package]; Contains: 04719894380896; Package: carton [10 Units]; In Commercial Distribution

FDA Product Code

• BZO: Set, Tubing And Support, Ventilator (W Harness)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

[14719894380893]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [VADI]

• 14719894380381: The Bacteria Filter Heater is designed to warm the patient's exhalation gas as it passes through
• 14719875347037: The Bacteria Filter Heater is designed to warm the patient's exhalation gas as it passes through
• 14719875347020: The Bacteria Filter Heater is designed to warm the patient's exhalation gas as it passes through
• 14719894380930: Reusable humidifier chamber
• 14719894380923: Disposable ventilator circuit/ tubing (Without heated wire)
• 04719894380919: Respiratory humidifier---Accessories- Heated wire (with port)
• 14719894380893: Reusable ventilator circuit/ tubing (Without heated wire)
• 14719894380886: Reusable ventilator circuit/ tubing (Without heated wire)