ASCENT BRS00040700

GUDID 00878528001928

ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 7mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter

Medos International Sàrl

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00878528001928
• NIH Device Record Key: df78884f-ec4a-4c63-8c4e-fa601fc91d8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASCENT
• Version Model Number: BRS000407-00
• Catalog Number: BRS00040700
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878528001928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103780

FDA Product Code

• MJN: Catheter, intravascular occluding, temporary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-06-30

On-Brand Devices [ASCENT]

• 00878528001935: ASCENT balloon catheter Occlusion Balloon Catheter 6mm x 9mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.
• 00878528001928: ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 7mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.
• 00878528001911: ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 15mm 150 cm 3 mm 2.9 F (0.98 mm) 0.0170
• 00878528001904: ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 10mm 150 cm 3 mm 2.9 F (0.98 mm) 0.0170