FDA UDI
In Commercial Distribution
🇺🇸 United States
EasiSlush
DI: 00860001991208
·
Model: BTLE-1250
·
Bridge To Life Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
8
Basic Information
- Brand Name
- EasiSlush
- Primary DI
- 00860001991208
- Version / Model
- BTLE-1250
- Company Name
- Bridge To Life Ltd.
- Labeler DUNS
- 830330457
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 8
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 1
- Public Version Date
- 2024-04-22
- Public Version Status
- New
- Public Device Record Key
- e7aaef20-b831-4b48-93ab-21bbed0d40b8
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Gastroenterology, Urology | 876.5880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44746 | Inhalation therapy saline solution, isotonic | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860001991208 | GS1 | ||||
| Unit of Use | 10860001991205 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191006 | 000 |