FDA.reportPublic FDA data

MYOtherm XP™

Primary DI
00763000218348
Brand
MYOtherm XP™
Company
MEDTRONIC, INC.
Model
XP41BT
Device description
CARDIOPLEGIA XP41BT MYOTHERM XP4 1BT 4PK
Published
2020-08-06
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
DTNReservoir, blood, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162958000MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with BridgeMedtronic, Inc.2017-02-01DTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000218342PackageGS14Not in Commercial Distribution
00763000218348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300021834220763000218342
00763000218348007630002183487630002183480763000218348

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Store the product at room temperature.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00199150044177Concerto Versa™CVP-152026-10-18
00199150044184Concerto Versa™CVP-302026-10-18
00199150044191Concerto Versa™CVP-402026-10-18
00199150044207Concerto Versa™CVP-652026-10-18
00763000387020Symplicity G3™RDNG3A2023-11-30
00824846020073NABB10E56R162026-10-01
00643169845893Reveal LINQ™LNQ112020-01-19
00199150032402SenSight™B31030-S2026-09-28
00199150032426SenSight™B31030-D2026-09-28
00763000923709Power CordMCS1621PC2026-09-25
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08054117378264HORIZON 8AFEUROSETS SRLDTN2026-10-15
00803622164859Perfusion PackLIVANOVA USA, INC.DTN2026-09-29
00803622164378Perfusion PackLIVANOVA USA, INC.DTN2026-09-22
08054117372446TRILLYEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113145INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
38033178113152INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114066XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114073XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114080XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114097XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178114103XTRASORIN GROUP ITALIA SRLDTN2024-12-20