EasiSlush

GUDID 00860001991208

EasiSlush (Sodium Chloride Solution for Sterile Slush Preparation) is 1.25L sterile 0.9% Sodium Chloride Solution in a 2L bag. It is used to establish, and maintain hypothermia of donor organs during recovery, storage, and transport.

Bridge To Life Ltd.

Inhalation therapy saline solution, isotonic

• Primary Device ID: 00860001991208
• NIH Device Record Key: e7aaef20-b831-4b48-93ab-21bbed0d40b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasiSlush
• Version Model Number: BTLE-1250
• Company DUNS: 830330457
• Company Name: Bridge To Life Ltd.
• Device Count: 8
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860001991208 [Primary]
GS1	10860001991205 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191006

FDA Product Code

• KDN: System, Perfusion, Kidney

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: 2024-04-22
• Device Publish Date: 2024-04-12