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 ID00860001991208
NIH Device Record Keye7aaef20-b831-4b48-93ab-21bbed0d40b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasiSlush
Version Model NumberBTLE-1250
Company DUNS830330457
Company NameBridge To Life Ltd.
Device Count8
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001991208 [Primary]
GS110860001991205 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KDNSystem, Perfusion, Kidney

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-22
Device Publish Date2024-04-12

Trademark Results [EasiSlush]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EASISLUSH
EASISLUSH
87074530 not registered Live/Pending
Bridge to Life, Ltd.
2016-06-16
EASISLUSH
EASISLUSH
85725089 not registered Dead/Abandoned
BTL Solutions, LLC
2012-09-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.