EasiSlush

Primary DI
00860001991208
Brand
EasiSlush
Company
Bridge To Life Ltd.
Model
BTLE-1250
Device description
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.
Published
2024-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KDNSystem, Perfusion, Kidney

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDNSystem, Perfusion, KidneyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191006000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191006000EasiSlushBridge TO Life, Ltd.2019-09-24KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001991208PrimaryGS10
10860001991205Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001991208008600019912088600019912080860001991208
1086000199120510860001991205

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy saline solution, isotonicA sterile, isotonic saline solution, consisting only of water and sodium chloride (NaCl), intended to be used to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases, and to help loosen secretions in the respiratory tract of the patient. It is intended to be used with a nebulizer to increase the humidity of respired air through the addition of atomized water to room air or to the gas stream of a breathing circuit. The solution is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the nebulizer. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830330457
Device count
8
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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