Carrier™ Delivery Catheter N/A

GUDID 00810068568059

The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.

BALT USA LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00810068568059
• NIH Device Record Key: 21665fb4-4122-4dcd-88fd-b6b2893bd0f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carrier™ Delivery Catheter
• Version Model Number: CR8081
• Catalog Number: N/A
• 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
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter
• Catheter Length: 152 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810068568059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230609

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2023-11-15
• Device Publish Date: 2023-11-07

On-Brand Devices [Carrier™ Delivery Catheter]

• 00810068568059: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The
• 00810068561982: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The
• 00810068561944: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The
• 00840303713500: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The
• 00840303713494: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The
• 00840303713487: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The