Aeris Balloon Dilation Catheter

GUDID KG0930

Aeris Balloon Dilation Catheter 9x30mm

BRYAN MEDICAL, INC.

Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter Bronchial balloon catheter

• Primary Device ID: KG0930
• NIH Device Record Key: 76ef5e82-c27e-4868-bef6-ce14f44dcddf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aeris Balloon Dilation Catheter
• Version Model Number: KG0930
• Company DUNS: 160067273
• Company Name: BRYAN MEDICAL, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	KG0930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150951

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

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: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Aeris Balloon Dilation Catheter]

• KG1840: Aeris Balloon Dilation Catheter 18x40mm
• KG1640: Aeris Balloon Dilation Catheter 16x40mm
• KG1240: Aeris Balloon Dilation Catheter 12x40mm
• KG1030: Aeris Balloon Dilation Catheter 10x30mm
• KG0930: Aeris Balloon Dilation Catheter 9x30mm
• KG0830: Aeris Balloon Dilation Catheter 8x30mm
• KG0730: Aeris Balloon Dilation Catheter 7x30mm
• KG0630: Aeris Balloon Dilation Catheter 6x30mm
• KG0530: Aeris Balloon Dilation Catheter 5x30mm