FDA UDI
Not in Commercial Distribution
🇺🇸 United States
XVIVO Lung Cannula Set II™
DI: 07350069520500
·
Model: 19023
·
Xvivo Perfusion AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XVIVO Lung Cannula Set II™
- Primary DI
- 07350069520500
- Version / Model
- 19023
- Catalog Number
- 19023
- Company Name
- Xvivo Perfusion AB
- Labeler DUNS
- 559895730
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-01
- Public Version
- 4
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- a12fe2eb-fa55-4cec-8153-1877b43ad203
- Distribution End Date
- 2021-10-14
Device Description
XVIVO Lung Cannula Set II™ is a sterile, single-use set intended to be used to connect isolated donor lungs to an extracorporeal perfusion system for ex-vivo assessment.
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 | 07350069520500 | GS1 |
Customer Contacts
- Phone
- +1 303 395 9171
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180014 | 000 |