FDA.reportPublic FDA data

Perfadex with THAM

Primary DI
07350069520067
Brand
Perfadex with THAM
Company
Xvivo Perfusion AB
Model
19018
Catalog number
19018
Device description
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.Package size 2 x 2800 ml
Published
2016-06-13
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
KDNSystem, Perfusion, Kidney

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDNSystem, Perfusion, KidneyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091989000PERFADEX AND PERFADEX WITH THAMXvivo Perfusion AB2010-10-01KDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350069520067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350069520067073500695200677350069520067

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+13033959171info@xvivoperfusion.com

Regulatory Flags#

DUNS number
559895730
Device count
1
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
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
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08052742104449Servator B SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104487Servator P SALF Solution with THAMS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
08052742104494Servator P SALF Solution with THAMS.A.L.F. SPA LABORATORIO FARMACOLOGICOKDN2026-05-26
13700911901000Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
13700911901017Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
13700911901024Perfusion CannulaINSTITUT GEORGES LOPEZKDN2026-05-11
40331330005006CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHKDN2025-09-19
07540161670214X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670221X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670238X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670245X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
07540161670269X°Port Lung Preservation SolutionTraferox Technologies IncKDN2025-09-11
00815045020605LifePort® Kidney TransporterORGAN RECOVERY SYSTEMS, INC.KDN2025-08-14
05906874879092LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
05906874879085LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
05906874879191LungProtect®CARNAMEDICA SP Z O OKDN2025-07-30
00198715358155Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284914773Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284309944Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284590434Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
00199284210417Belzer UW Cold Storage SolutionBridge To Life Ltd.KDN2025-06-17
13700911901055Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
07540161670153X°Port Lung Preservation SystemTraferox Technologies IncKDN2025-05-26
13700911900577DCX Disposable CassetteINSTITUT GEORGES LOPEZKDN2025-05-26
23700911901052Perfusion CouplerINSTITUT GEORGES LOPEZKDN2025-05-26
00850005470625KidneyVaultParagonix Technologies IncKDN2025-02-25
00850005470632KidneyVaultParagonix Technologies IncKDN2025-02-25