FDA.reportPublic FDA data

Servator H

Primary DI
00851983008060
Brand
Servator H
Company
GLOBAL TRANSPLANT SOLUTIONS, INC.
Model
GTS-SERV-HTK-5000
Device description
Servator H Solution is intended for flushing and cold storage of abdominal organs at the time of removal from the donor in preparation fort storage, transportation, and the eventual transplantation into a recipient.
Published
2020-04-21
Public version status
New
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
MSBSystem And Accessories, Isolated Heart, Transport And Preservation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSBSystem And Accessories, Isolated Heart, Transport And PreservationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851983008060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851983008060008519830080608519830080600851983008060

GMDN Terms#

Term, Definition table
TermDefinition
Kidney donor-organ preservation/transport perfusion setA collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
(833) 264-8849jbruens@1GTSInc.com

Regulatory Flags#

DUNS number
021248196
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052742104401Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104418Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104425Servator H SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
08052742104456Servator C SALF SolutionS.A.L.F. SPA LABORATORIO FARMACOLOGICOMSB2026-05-26
40331330005006CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330010000CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
40331330020009CustodiolDr. Franz Köhler Chemie GmbHMSB2025-09-19
00850005470649SherpaPak Cardiac Transport System (CTS)Paragonix Technologies IncMSB2025-05-05
04033133420007Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2023-07-03
B00958753OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
B00958755OCS Lung Donor Flush SetTRANSMEDICS, INC.MSB2023-06-13
13700911900126CELSIOR Cold Storage SolutionINSTITUT GEORGES LOPEZMSB2022-02-07
04033133611016Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-08-08
04033133105003Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133250000Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
04033133610002Custodiol(R)Dr. Franz Köhler Chemie GmbHMSB2019-05-09
00869582000316Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10850005470271Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
10869582000313Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000323Paragonix SherpaPak Cardiac Transport SystemPARAGONIX TECHNOLOGIES INCMSB2019-02-15
00869582000330Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000347Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000354Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000361Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000378Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
00869582000385Paragonix SherpaPak Cardiac Transport SystemParagonix Technologies IncMSB2019-02-15
B00944670OCS Lung SystemTRANSMEDICS, INC.MSB2018-06-01
40331330610002CustodiolDr. Franz Köhler Chemie GmbHMSB2016-09-22