FDA.reportPublic FDA data

NA

Primary DI
00763000076368
Brand
NA
Company
MEDTRONIC, INC.
Model
2U37R3
Device description
CUSTOM PACK 2U37R3 5PK SUPPMENT LN
Published
2017-11-25
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
DWETUBING, PUMP, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWETubing, Pump, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800178000EXTRACORP.'S INTERSEPT CUS. TUBING PK.Extracorporeal Medical Specialities, Inc.1980-02-21DWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000076379PackageGS15In Commercial Distribution
00763000076368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300007637920763000076379
00763000076368007630000763687630000763680763000076368

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 Temperature0 Degrees Celsius50 Degrees Celsius

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
00613994391551NA6207-S52017-01-03
00613994391568NA6208-S52017-01-03
00613994391575NA6209-S52017-01-03
00613994391582NA6210-S52017-01-03
00613994397829NA6211-S52017-01-03
00643169002913Stretch™ Insertion Tool0060732016-07-02
00643169013964NA2082112017-02-02
00643169013988NA2072232017-02-03
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014022NA2062232017-02-03
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00803622164965Perfusion PackLIVANOVA USA, INC.DWE2026-10-22
00803622164804Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164811Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164842Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164927Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164934Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164941Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164958Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164989Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164996Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165047Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622165054Perfusion PackLIVANOVA USA, INC.DWE2026-10-19
00803622164774Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164781Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164798Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164866Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164873Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164880Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164897Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164903Perfusion PackLIVANOVA USA, INC.DWE2026-10-06
00803622164736Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164743Perfusion PackLIVANOVA USA, INC.DWE2026-09-29
00803622164651Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164675Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164682Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164705Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164712Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164729Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164767Perfusion PackLIVANOVA USA, INC.DWE2026-09-28
00803622164477Perfusion PackLIVANOVA USA, INC.DWE2026-09-22