FDA.reportPublic FDA data

CB MYOTherm XP®

Primary DI
00613994947789
Brand
CB MYOTherm XP®
Company
MEDTRONIC, INC.
Model
CBXP41
Device description
HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK
Published
2015-06-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003724000CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-BMedtronic Vascular2000-12-21DTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994947783PackageGS14Not in Commercial Distribution
00613994947789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399494778320613994947783
00613994947789006139949477896139949477890613994947789

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
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

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
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
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 ISO 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
08051160301195Quantum PureFlow Standard Heat Exchanger Low Flow 3/16SPECTRUM MEDICAL SRLDTR2022-02-16