Balloon Catheter Syringe Pump FG4011

GUDID 06938695537775

Balloon Catheter Syringe Pump, Tube Length 30cm

Shanghai Kinetic Medical Co., Ltd.

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• Primary Device ID: 06938695537775
• NIH Device Record Key: 70d4d819-ac49-4acd-9f56-082bea3b40a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Catheter Syringe Pump
• Version Model Number: FG4011
• Catalog Number: FG4011
• Company DUNS: 528198569
• Company Name: Shanghai Kinetic Medical Co., Ltd.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch
• Length: 30 Centimeter
• Pressure: 440 Pound per Square Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938695537775 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113742

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-08
• Device Publish Date: 2020-05-31

On-Brand Devices [Balloon Catheter Syringe Pump]

• 06938695537782: Balloon Catheter Syringe Pump, Tube Length 60cm
• 06938695537775: Balloon Catheter Syringe Pump, Tube Length 30cm