FDA.reportPublic FDA data

MYOtherm XP™

Primary DI
20763000218991
Brand
MYOtherm XP™
Company
MEDTRONIC, INC.
Model
CBXP41B
Device description
HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK
Published
2020-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000218991PackageGS14In Commercial Distribution
00763000218997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300021899120763000218991
00763000218997007630002189977630002189970763000218997

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration kitA collection of sterile devices intended to be used to inject 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 Celsius40 Degrees Celsius
Special Storage Condition, Specify00Store the product at room temperature.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000923594HeartWare™ Monitor1521MCS2026-09-25
00763000923709Power CordMCS1621PC2026-09-25
00763000923792Monitor Power CordMCS1622PC2026-09-25
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
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08054117372545HORIZONEUROSETS SRLDTR2026-05-05
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
05060434420831QuantumSPECTRUM MEDICAL LIMITEDDTR2026-02-27
18051160302236Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
18051160302274Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
05060912587483CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2025-02-07
18051160302205Quantum PureFlow Standard Heat Exchanger High Flow 3/8 WSPECTRUM MEDICAL SRLDTR2024-11-19
18051160302267Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 WSPECTRUM MEDICAL SRLDTR2024-11-19
05060491619810CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2024-10-07
04987350743251CAPIOXTERUMO CORPORATIONDTR2024-05-20
54987350743256CAPIOXTERUMO CORPORATIONDTR2024-05-20
08033178112840KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
38033178113466KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
05060491614129Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCHALICE MEDICAL LIMITEDDTR2023-11-07
20634624530380MPS 3 Medical Air Hose KitQUEST MEDICAL INCDTR2023-10-16
05415067036414CentriMag™Thoratec CorporationDTR2023-05-17
18051160302168Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 MSPECTRUM MEDICAL SRLDTR2023-05-04
18051160302175Quantum PureFlow Standard Heat Exchanger High Flow 3/8 MSPECTRUM MEDICAL SRLDTR2023-05-04
20634624530397MPS 3 Drug Pump CoverQUEST MEDICAL INCDTR2023-03-24
08051160301003Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8SPECTRUM MEDICAL SRLDTR2022-05-30
08051160301171Quantum PureFlow Standard Heat Exchanger High Flow 3/8SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301188Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16