FDA UDI
In Commercial Distribution
🇺🇸 United States
XVIVO Perfusion System (XPS™)
DI: 07350069520104
·
Model: 19030
·
Xvivo Perfusion AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XVIVO Perfusion System (XPS™)
- Primary DI
- 07350069520104
- Version / Model
- 19030
- Catalog Number
- 19030
- Company Name
- Xvivo Perfusion AB
- Labeler DUNS
- 559895730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 4
- Public Version Date
- 2021-10-14
- Public Version Status
- Update
- Public Device Record Key
- d1d0ddbc-e0b5-46c3-8953-fcc925b39564
Device Description
The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58266 | Lung donor-organ preservation/evaluation system | An assembly of devices designed to be used for the reconditioning, ex-vivo evaluation and cold preservation of donated lungs prior to transplantation. It typically consists of a mains electricity (AC-powered) unit which includes an operator's console, a roller pump, monitor, heat exchanger unit and gas system. The lungs are placed in a disposable chamber where they are connected, via tubing, to the evaluation unit. Typically, measurements can be made of pulmonary pressure, temperature, and flow, with calculation of pulmonary vascular resistance. The system is intended for use in a hospital in a clean area and is mobile on wheels. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350069520104 | GS1 |
Customer Contacts
- Phone
- +1 303 395 9171
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius