FDA.reportPublic FDA data

Bio-Medicus Life Support™

Primary DI
00763000615550
Brand
Bio-Medicus Life Support™
Company
MEDTRONIC, INC.
Model
LS96438-025
Device description
CATHETER LS96438-025 BIO-MED VEN 25FR
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
00763000615550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000615550007630006155507630006155500763000615550

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 Gauge25French
Catheter Length38Centimeter

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
00199150070114NAC320LBBL452026-04-13
00199150070121NAC320LBBL482026-04-13
00199150070138NAC320LBBS452026-04-13
00199150070145NAC320LBBS482026-04-13
00613994764546SHERPA NX BALANCEDSB8JR4052016-07-31
00613994764577SHERPA NX BALANCEDSB8JR3552016-07-31
00613994765055SHERPA NX BALANCEDSB8JL5052016-07-31
00613994765116SHERPA NX BALANCEDSB8JL4052016-07-31
00613994765147SHERPA NX BALANCEDSB8JL3552016-07-31
00613994766458SHERPA NX BALANCEDSB8AL1052016-06-12
00613994766526SHERPA NX BALANCEDSB8AR2052016-06-12
00613994766557SHERPA NX BALANCEDSB8AR1052016-06-12
00613994767158SHERPA NX BALANCEDSB8EBU4552016-06-12
00613994767196SHERPA NX BALANCEDSB8EBU4052016-06-12
00613994767240SHERPA NX BALANCEDSB8EBU3552016-06-12
00613994768018LauncherLA8JL5052016-04-08
00613994768124LauncherLA8JL4052016-04-15
00613994768308LauncherLA8JR4052016-09-01
00613994768353LauncherLA8JR3552016-04-07
00613994769497LauncherLA8AR2052016-04-16

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
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
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