FDA.reportPublic FDA data

NA

Primary DI
00763000298937
Brand
NA
Company
MEDTRONIC, INC.
Model
SSHY8E13R11
Device description
CUSTOM PACK SSHY8E13R11 TOTAL VS
Published
2019-08-16
Public version status
Update
Distribution status
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
DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171308000Tubing PackMedtronic, Inc.2017-06-02DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000298937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000298937007630002989377630002989370763000298937

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system tubing setA collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary bypass procedure. The tubing is typically polymeric and may be heparin coated. It is typically used in the blood pump head of a cardiopulmonary bypass system. The tubing, when used in a roller type pump, will be cyclically compressed by the blood pump to cause the blood to flow through the heart-lung bypass system. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 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
Kit
true
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
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178112840KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113342INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08052705496253A.M.G. PP SterileEUROSETS SRLDTZ2020-05-11
08033178113182INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113212INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113236INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08034013782020A.M.G. PMP SterileEUROSETS SRLDTZ2017-02-28
08033178250313RESERVOIRSORIN GROUP ITALIA SRLDTZ2016-09-15
00613994617309Affinity Pixie™MEDTRONIC, INC.DTZ2016-06-02
00643169178144Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
00643169354869Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
10887488435152CARDINAL HEALTHCardinal Health 200, LLCDTZ2016-01-27
08033178112758LILLIPUT PMPSORIN GROUP ITALIA SRLDTZ2015-11-25
00613994375636TRILLIUM® AFFINITY NT®MEDTRONIC, INC.DTZ2015-09-21
H965700393540NAMICNAVILYST MEDICAL, INC.DTZ2015-09-16