FDA.reportPublic FDA data

Bio-Medicus Life Support™

Primary DI
00763000615369
Brand
Bio-Medicus Life Support™
Company
MEDTRONIC, INC.
Model
LS96010-015
Device description
CATHETER LS96010-015 BIO-MED ART 15FR
Published
2022-07-07
Public version status
Update
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
QHWSingle lumen ECMO cannula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QHWSingle Lumen Ecmo CannulaCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201057000
K201100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201057000Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2022-01-14QHW
K201100000Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2021-07-15DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000615369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000615369007630006153697630006153690763000615369

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, arterialA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted for perfusion of the ascending aorta, serving as a channel for the transport of pumped, oxygenated, blood from a cardiopulmonary bypass system (heart-lung machine) tubing circuit. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, having multiple perforations or flutes at the distal end which help diffuse and disperse incoming blood. It may be inserted using a compatible trocar. Some types may be heparin coated and include a pressure monitoring port. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge15French
Catheter Length11.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry
Storage Environment Temperature0 Degrees Celsius25 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
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23
00199150080700NABB11E27R32026-05-23
00199150081004NABB11J58R82026-05-23
00199150081011NABB12T50R32026-05-23
00199150081035NABB7E31R342026-05-22
00199150081042NA12D63R22026-05-22
00199150081066NA4J31R12026-05-23
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22
00613994963819Sones™ C0087202016-06-05
00613994963833NIH™0087622016-07-24
00613994963840NIH™0087632016-06-10
00613994963987Sones™ Brachial0077702016-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000615338Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615345Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615352Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615376Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615383Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615390Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615406Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615413Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615420Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615437Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615444Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615451Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615468Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615475Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615482Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615499Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615505Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615512Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615529Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615536Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615543Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615550Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615567Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615574Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615581Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615598Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615604Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00888867276215Arthrex®ARTHREX, INC.QHW2021-05-26