FDA.reportPublic FDA data

XVIVO Lung Disposables Kit

Primary DI
07350069520142
Brand
XVIVO Lung Disposables Kit
Company
Xvivo Perfusion AB
Model
19035
Catalog number
19035
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.
Published
2015-10-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor LungsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350069520142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520142073500695201427350069520142

GMDN Terms#

Term, Definition table
TermDefinition
Lung donor-organ preservation/evaluation system chamber setA collection of sterile devices intended to be used with a lung donor-organ preservation/evaluation system. It typically consists of a lung chamber with tubing and a fluid reservoir, oxygenator, leukocyte filter, pressure sensors and a connection for a ventilator with a humidity filter that creates an ex-vivo environment for the preservation, reconditioning and evaluation of the organs. It typically includes surgical drapes to create a sterile field for surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 303 395 9171info@xvivoperfusion.com
+1 303 395 9171info@xvivogroup.com

Regulatory Flags#

DUNS number
559895730
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350069520623XVIVO Disposable Lung Kit 19046190462025-11-10
07350069520401XVIVO Disposable Lung Kit19046190462023-09-29
07350069520234PERFADEX Plus®19800198002019-12-04
07350069520241PERFADEX Plus®19900199002019-12-04
07350069520296PERFADEX® Plus19950199502018-09-19
07350069520289PERFADEX Plus (Click US)19850198502019-12-04
07350069520036STEEN Solution™19004190042015-10-15
07350069520050Perfadex with THAM19017190172016-06-13
07350069520067Perfadex with THAM19018190182016-06-13
07350069520500XVIVO Lung Cannula Set II™ 19023190232021-10-01
07350069520074XVIVO Organ Chamber™19020190202015-10-15
07350069520098XVIVO Lung Cannula Set™19022190222015-10-15
07350069520111XVIVO PGM Disposable Sensors™ 19033190332015-10-15
07350069520425XVIVO Click Adapter19024190242021-10-29
07350069520104XVIVO Perfusion System (XPS™)19030190302015-10-15
07350069520043Silicon Tubing Set19005190052016-11-11
07350069520302XVIVO Click Adapter19125191252018-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350069520623XVIVO Disposable Lung Kit Xvivo Perfusion ABPHO2025-11-10
07350069520401XVIVO Disposable Lung KitXvivo Perfusion ABPHO2023-09-29
07350069520500XVIVO Lung Cannula Set II™ Xvivo Perfusion ABPHO2021-10-01
07350069520036STEEN Solution™Xvivo Perfusion ABPHO2015-10-15
07350069520074XVIVO Organ Chamber™Xvivo Perfusion ABPHO2015-10-15
07350069520098XVIVO Lung Cannula Set™Xvivo Perfusion ABPHO2015-10-15
07350069520104XVIVO Perfusion System (XPS™)Xvivo Perfusion ABPHO2015-10-15
07350069520111XVIVO PGM Disposable Sensors™ Xvivo Perfusion ABPHO2015-10-15