FDA.reportPublic FDA data

NA

Primary DI
20763000294650
Brand
NA
Company
MEDTRONIC, INC.
Model
11A75R1
Device description
CUSTOM PACK 11A75R1 20PK PIGTAIL IN
Published
2019-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20763000294650PackageGS120In Commercial Distribution
00763000294649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300029465020763000294650
00763000294649007630002946497630002946490763000294649

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 Celsius50 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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