Lumiflex 00715512W

GUDID 00724995244576

LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressive stage balloon capable of three disctinct and progressively larger diameters via controlled radial expansion.

US Endoscopy

Gastrointestinal/biliary dilation balloon catheter, non-medicated

• Primary Device ID: 00724995244576
• NIH Device Record Key: 2855e977-9fb5-4116-8da6-688d5c5988dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lumiflex
• Version Model Number: 00715512W
• Catalog Number: 00715512W
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter
• Guidewire Diameter: 0.89 Millimeter
• Balloon Length: 5.5 Centimeter
• Catheter Length: 240 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark, dry and ventilated place to prevent impact by rain, snow and ground moisture. Do not store near pollution or toxic chemicals materials.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995244576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241888

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

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: 2025-06-11
• Device Publish Date: 2025-06-03

On-Brand Devices [Lumiflex]

• 00724995244712: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0 cm-18mm wire is made of nylon and is a progress
• 00724995244705: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/15mm wire is made of nylon and is a progressi
• 00724995244699: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/12mm wire is made of nylon and is a progressi
• 00724995244682: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/10mm wire is made of nylon and is a progressi
• 00724995244675: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/8mm wire is made of nylon and is a progressiv
• 00724995244668: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 8.0cm/6mm wire is made of nylon and is a progressiv
• 00724995244651: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm no wire is made of nylon and is a progre
• 00724995244644: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm no wire is made of nylon and is a progre
• 00724995244637: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm no wire is made of nylon and is a progre
• 00724995244620: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm no wire is made of nylon and is a progre
• 00724995244613: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm no wire is made of nylon and is a progres
• 00724995244606: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm no wire is made of nylon and is a progres
• 00724995244590: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/18mm wire is made of nylon and is a progressi
• 00724995244583: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/15mm wire is made of nylon and is a progressi
• 00724995244576: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/12mm wire is made of nylon and is a progressi
• 00724995244569: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/10mm wire is made of nylon and is a progressi
• 00724995244552: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/8mm wire is made of nylon and is a progressiv
• 00724995244545: LUMIFLEX 3-STAGE Balloon Dilatation Catheter 5.5cm/6mm wire is made of nylon and is a progressiv