VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit
Basic Information
- Brand Name
- VitaSmart Hypothermic Oxygenated Perfusion System-VitaSmart Liver Perfusion Kit
- Primary DI
- 00199284522503
- Version / Model
- V0002-US
- Company Name
- Bridge To Life Ltd.
- Labeler DUNS
- 830330457
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-20
- Public Version
- 3
- Public Version Date
- 2026-03-12
- Public Version Status
- Update
- Public Device Record Key
- bf7be3d8-c0c5-4e0f-920d-1fc63eb36045
Device Description
The VitaSmart Hypothermic Oxygenated Perfusion System (VitaSmart HOPE System; VitaSmart System) is intended to be used for the hypothermic oxygenated perfusion of livers (via the portal vein) for preservation and transplantation into a receiving patient. The VitaSmart HOPE System is intended to be used by healthcare professionals within a professional healthcare facility and is not intended to be used in transport. The VitaSmart System is comprised of two primary components: the reusable Base Unit (consisting of system electronics, pump control, perfusion sensors, user interface, and portable stand or trolley), and the disposable Perfusion Kit (consisting of tubing set, oxygenator, RFID tag, arterial filter). The VitaSmart HOPE System pumps oxygenated perfusion solution through the connected disposable Perfusion Kit that is connected to the organ (liver) with the Base Unit controlling and monitoring via the pump control and perfusion sensors. Alarms have been developed to communicate with the user and ensure that proper perfusion is occurring.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | Gastroenterology, Urology | 876.5881 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00199284522503 | GS1 |
Customer Contacts
- Phone
- (803) 545-0080
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN250009 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 35 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal