FDA.reportPublic FDA data

NA

Primary DI
00613994258106
Brand
NA
Company
MEDTRONIC, INC.
Model
LST
Device description
TAPE LST LEVEL DETECTOR MOUNT
Published
2015-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWAControl, pump speed, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070286000
K150530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070286000BIO-CONSOLE, MODEL 560Medtronic2007-05-22DWA
K150530000Level Sensor, Level Sensor TapeMedtronic, Inc.2015-05-08DTW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994258106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994258106006139942581066139942581060613994258106

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Atmospheric Limitation of 700 hPa to 1060 hPa
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius66 Degrees Celsius

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
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
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00850000067141Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2025-08-26
07290117830055INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830062INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830093INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830147INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830048INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830052INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830069INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830086INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830090INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830109INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
07290117830116INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
17290117830144INSPIRA ART100 INSPIRA TECHNOLOGIES OXY B.H.N LTDDWA2024-11-10
00850000067059Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067066Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067073Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067080Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067097Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067103Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067110Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
00850000067127Anivia SG1000 Pump ConsoleAPMTD, Inc.DWA2024-09-11
04897102200065Anivia SG1000 Pump ConsoleAsia Pacific Medical Technology Development Company LimitedDWA2024-09-11
05415067036414CentriMag™Thoratec CorporationDWA2023-05-17
00763000301347NAMEDTRONIC, INC.DWA2023-03-18
00814112020586LifeSPARCCARDIACASSIST, INC.DWA2023-02-24
00814112020906LifeSPARCCARDIACASSIST, INC.DWA2022-05-10
04033817902782CP5LivaNova Deutschland GmbHDWA2021-05-14
10860001797968OXY-1 SystemBreethe, Inc.DWA2020-12-02
00860001797961OXY-1 SystemBreethe, Inc.DWA2020-12-02