Magic Infusion Catheter

GUDID 00818053022821

Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature.

BALT USA LLC

Vascular microcatheter

• Primary Device ID: 00818053022821
• NIH Device Record Key: 678c6f53-329a-4d4e-b088-aeebb9cf6543
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magic Infusion Catheter
• Version Model Number: MA1.2FOLIVE
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• 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: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place at room temperature and away from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818053022821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023351

FDA Product Code

• KRA: Catheter, Continuous Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-09
• Device Publish Date: 2018-12-01

On-Brand Devices [Magic Infusion Catheter]

• 00818053022838: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022821: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022647: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022630: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022623: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022616: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022609: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022593: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
• 00818053022586: Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into