FDA.reportPublic FDA data

Bio-Medicus Life Support™

Primary DI
00763000615383
Brand
Bio-Medicus Life Support™
Company
MEDTRONIC, INC.
Model
LS96110-011
Device description
CATHETER LS96110-011 BIO-MED VEN 11FR
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
00763000615383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000615383007630006153837630006153830763000615383

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass cannula, venousA sterile, semi-rigid or rigid tube intended to be used during open heart surgery where it is surgically inserted, typically into the right atrium and superior/inferior vena cava, to serve as a channel for the transport of blood to a cardiopulmonary bypass system (heart-lung machine) tubing circuit where the blood is pumped and oxygenated. It is typically a moulded plastic tube with stainless steel wire reinforcement, to prevent kinking/collapse, and having multiple perforations at the distal end and possibly a non-reinforced clamping site at the proximal end. It is typically inserted using a compatible trocar. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge11French
Catheter Length10.5Centimeter

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
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

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
00763000615369Bio-Medicus Life Support™MEDTRONIC, INC.QHW2022-07-07
00763000615376Bio-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