KMC Medical Balloon Catheter Syringe Pump

GUDID 06938695540010

KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KMC Medical Balloon Catheter Syringe Pump

Shanghai Kinetic Medical Co., Ltd.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 06938695540010
• NIH Device Record Key: f9966ab8-cce6-4c8a-8412-22cd38d012c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KMC Medical Balloon Catheter Syringe Pump
• Version Model Number: FG4001
• 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

• Pressure: 440 Pound per Square Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938695540010 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-01-06

On-Brand Devices [KMC Medical Balloon Catheter Syringe Pump]

• 06938695540058: KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM
• 06938695540010: KMC Kyphoplasty System consists of four components: Balloon Catheter Tool Kit Puncture Needle KM