Revere Hybrid Access Catheter N/A

GUDID 00840303712763

Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stiffness catheter with a radiopaque zone on the distal end and a luer hub on the proximal end. The catheter is provided sterile, non-pyrogenic, and is intended for single use only.

BALT USA LLC

Vascular guide-catheter, single-use

• Primary Device ID: 00840303712763
• NIH Device Record Key: dbd7c79b-fe83-4538-aaf2-e6f94e2b9a69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revere Hybrid Access Catheter
• Version Model Number: REVERE6F80
• 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 Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• Device Size Text, specify: 0
• Catheter Working Length: 80 Centimeter
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00840303712763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182918

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: 2024-08-22
• Device Publish Date: 2024-08-14

On-Brand Devices [Revere Hybrid Access Catheter]

• 00840303712770: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712763: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712756: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712749: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712732: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712725: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712718: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712701: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif
• 00840303712695: Revere Hybrid Access Catheter is a single lumen, hybrid coil and braid-reinforced, variable stif