FDA.reportPublic FDA data

NA

Primary DI
00199150081066
Brand
NA
Company
MEDTRONIC, INC.
Model
4J31R1
Device description
CUSTOM PACK 4J31R1 ACC CCLS EXT
Published
2026-05-23
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
DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171979000Tubing PackMedtronic, Inc.2017-10-27DWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199150081066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199150081066001991500810661991500810660199150081066

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood 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 Temperature00

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
00613994963826NIH™0087612016-07-24
00613994964274NIH™ Cardio-Marker0100112016-06-10
00613994964540Lehman™0012592016-06-05
00613994964564Lehman™0012632016-06-05
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00681490860659DLPCB140172016-05-22
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
00199150081707NABB11J59R92026-05-22
00199150081714NABB11U73R22026-05-23
00199150081738NABB11J16R32026-05-22
00199150081745NA9M68R12026-05-23
00199150082902NABB12W52R2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150080649NAMEDTRONIC, INC.DWF2026-05-23
00199150080694NAMEDTRONIC, INC.DWF2026-05-23
00199150080700NAMEDTRONIC, INC.DWF2026-05-23
00199150081004NAMEDTRONIC, INC.DWF2026-05-23
00199150081011NAMEDTRONIC, INC.DWF2026-05-23
00199150081714NAMEDTRONIC, INC.DWF2026-05-23
00199150081745NAMEDTRONIC, INC.DWF2026-05-23
00199150081035NAMEDTRONIC, INC.DWF2026-05-22
00199150081042NAMEDTRONIC, INC.DWF2026-05-22
00199150081707NAMEDTRONIC, INC.DWF2026-05-22
00199150081738NAMEDTRONIC, INC.DWF2026-05-22
00199150082902NAMEDTRONIC, INC.DWF2026-05-22
20199150073652NAMEDTRONIC, INC.DWF2026-03-22
20199150073676NAMEDTRONIC, INC.DWF2026-03-22
20199150073690NAMEDTRONIC, INC.DWF2026-03-22
00199150073894NAMEDTRONIC, INC.DWF2026-03-22
00199150073900NAMEDTRONIC, INC.DWF2026-03-22
20199150073928NAMEDTRONIC, INC.DWF2026-03-22
20199150074116NAMEDTRONIC, INC.DWF2026-03-22
00199150074365NAMEDTRONIC, INC.DWF2026-03-22
20763000990286NAMEDTRONIC, INC.DWF2026-03-16
00199150071623NAMEDTRONIC, INC.DWF2026-03-07
20199150071917NAMEDTRONIC, INC.DWF2026-03-07
00199150071920NAMEDTRONIC, INC.DWF2026-03-07
00199150071937NAMEDTRONIC, INC.DWF2026-03-07
00199150071944NAMEDTRONIC, INC.DWF2026-03-07
20199150072020NAMEDTRONIC, INC.DWF2026-03-07
00199150072033NAMEDTRONIC, INC.DWF2026-03-07
00199150072040NAMEDTRONIC, INC.DWF2026-03-07
00199150072347NAMEDTRONIC, INC.DWF2026-03-07