FDA.reportPublic FDA data

STEEN Solution™

Primary DI
07350069520036
Brand
STEEN Solution™
Company
Xvivo Perfusion AB
Model
19004
Catalog number
19004
Device description
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Published
2015-10-15
Public version status
Update
Distribution status
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
07350069520036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520036073500695200367350069520036

GMDN Terms#

Term, Definition table
TermDefinition
Donor-organ preservation solutionA sterile solution intended to be used in conjunction with a donor-organ preservation/transport set for the flushing, transport, storage and preservation of donor organs (e.g., kidney, liver, heart, and pancreas) intended for transplantation. The solution contains a mixture of chemicals/ingredients intended to maintain organ viability until the organ can be implanted in the recipient; the solution may be combined with blood. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store dark with the bottle in an up-right position
Storage Environment Temperature2 Degrees Celsius8 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
Combination product
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
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
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
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