Identity
- Trade Name
- EasiSlush FDA UDI
- Generic Name
- Inhalation therapy saline solution, isotonic FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- BTLE-1250 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001991208 FDA UDI
- 510(k) Number
- K191006 FDA UDI
- FDA Product Code
- KDN FDA UDI
- GMDN Term
- Inhalation therapy saline solution, isotonic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inhalation therapy saline solution, isotonic
EasiSlush by Bridge to Life Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Inhalation therapy saline solution, isotonic.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bridge to Life Ltd
Sources (1)
- FDA UDI e7aaef20-b831-4b48-93ab-21bbed0d40b8 34 fields · synced May 30, 2026