FDA.reportPublic FDA data

XVIVO PGM Disposable Sensors™

Primary DI
07350069520111
Brand
XVIVO PGM Disposable Sensors™
Company
Xvivo Perfusion AB
Model
19033
Catalog number
19033
Device description
The XVIVO PGM Disposable Sensors™ are a single-use, disposable in-line sensor intended to be used with the XVIVO Perfusion System (XPS™) to monitor the pH and dissolved pO2 gas in STEEN Solution™ during ex-vivo lung assessment.
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07350069520111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520111073500695201117350069520111

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
559895730
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
07350069520142XVIVO Lung Disposables Kit19035190352015-10-15
07350069520500XVIVO Lung Cannula Set II™ 19023190232021-10-01
07350069520074XVIVO Organ Chamber™19020190202015-10-15
07350069520098XVIVO Lung Cannula Set™19022190222015-10-15
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
07350069520142XVIVO Lung Disposables KitXvivo Perfusion ABPHO2015-10-15