XVIVO Lung Cannula Set II™

Primary DI
07350069520500
Brand
XVIVO Lung Cannula Set II™
Company
Xvivo Perfusion AB
Model
19023
Catalog number
19023
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.
Published
2021-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180014000XPS™ with Steen Solution™ PerfusateXvivo Perfusion, Inc.2019-04-26PHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350069520500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520500073500695205007350069520500

GMDN Terms#

Term, Definition table
TermDefinition
Lung donor-organ perfusion system circuit setA collection of devices intended to be used with a lung donor-organ perfusion system to provide the fluid and gas pathways necessary for continuous ex vivo perfusion and ventilation of a donated lung(s) during preservation, evaluation and/or transport prior to transplantation. It includes many/most of the disposable components required for perfusion/fluid-delivery, which may include tubing, filters, valves, sensors, waste bag, centrifugal pump, oxygenator module, lung chamber, cannulae and perfusate solution. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
559895730
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350069520623XVIVO Disposable Lung Kit19046190462025-11-10
07350069520401XVIVO Disposable Lung Kit19046190462023-09-29
07350069520074XVIVO Organ Chamber™19020190202015-10-15
07350069520098XVIVO Lung Cannula Set™19022190222015-10-15
07350069520104XVIVO Perfusion System (XPS™)19030190302015-10-15
07350069520111XVIVO PGM Disposable Sensors™19033190332015-10-15
07350069520142XVIVO Lung Disposables Kit19035190352015-10-15
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
07350069520425XVIVO Click Adapter19024190242021-10-29
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 KitXvivo Perfusion ABPHO2025-11-10
07350069520401XVIVO Disposable Lung KitXvivo Perfusion ABPHO2023-09-29
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
07350069520142XVIVO Lung Disposables KitXvivo Perfusion ABPHO2015-10-15