FDA UDI
In Commercial Distribution
🇺🇸 United States
XVIVO Disposable Lung Kit
DI: 07350069520401
·
Model: 19046
·
Xvivo Perfusion AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XVIVO Disposable Lung Kit
- Primary DI
- 07350069520401
- Version / Model
- 19046
- Catalog Number
- 19046
- Company Name
- Xvivo Perfusion AB
- Labeler DUNS
- 559895730
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 1b91da75-7a9d-499a-8ec9-039308a69650
Device Description
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
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 |
|---|---|---|---|---|
| PHO | Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58267 | Lung donor-organ preservation/evaluation system lung-interface set | A collection of disposable devices intended to be used with a lung donor-organ preservation/evaluation system to house, supply oxygen to, and/or manage preservation solution for, the preserved lung(s). It typically consists of the following components: a lung chamber, breathing circuit tubing, a configuration of fluid delivery tubing, a fluid reservoir, oxygenator components, filter(s), sensors, and may also include surgical drapes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07350069520401 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180014 | 000 |