SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System 3001

GUDID 08600035053013

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Small size.

East End Medical I LLC

Cardiac septostomy catheter, balloon

• Primary Device ID: 08600035053013
• NIH Device Record Key: edadb073-5845-45c0-bd8f-b67c73d0ca54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
• Version Model Number: 3001
• Catalog Number: 3001
• Company DUNS: 118148023
• Company Name: East End Medical I 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 954-507-7887
• Email: mani@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com
• Phone: 9542406694
• Email: ccruz@eastendmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between -30 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08600035053013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203459

FDA Product Code

• DYB: Introducer, Catheter

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: 2022-04-13
• Device Publish Date: 2022-04-05

On-Brand Devices [SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System]

• 08600035053013: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Small size.
• 08600035053037: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System. Large size.
• 08600035053020: SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System, Medium.