FDA.reportPublic FDA data

DLP®

Primary DI
20613994846628
Brand
DLP®
Company
MEDTRONIC, INC.
Model
61006
Device description
SET 61006 PRESSURE DISPLAY 72 5PK 17L
Published
2016-06-13
Public version status
Update
Distribution status
Not 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
DXSGAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXSGauge, Pressure, Coronary, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K852232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K852232000PRESSURE DISPLAY BOX #60000/TUBING SET #61000Dlp, Inc.1985-08-09DXS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994846628PrimaryGS10
00613994846624Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399484662820613994846628
00613994846624006139948466246139948466240613994846624

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length182.9Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000443214NA2ACHC2024-05-18
00763000368470Aurora EV-ICD™ MRI SureScan™DVEA3E42023-11-02
00763000001513Primo MRI™ DR SureScan™DDMD3D42018-06-02
00763000001551Primo MRI™ VR SureScan™DVMD3D42018-06-02
00763000059491Evera MRI™ XT DR SureScan®DDMB1D42017-10-20
00763000059651Viva™ Quad XT CRT-DDTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DDTBA1D42017-10-21
00763000059705Evera MRI™ S DR SureScan®DDMC3D42017-10-21
00643169314092Evera MRI™ XT DR SureScan®DDMB1D42015-09-21
00643169314153Evera MRI™ XT VR SureScan®DVMB1D42015-09-21
00643169720497Evera MRI™ XT DR SureScan®DDMB1D42017-09-15
00643169735637Percepta™ CRT-P MRI SureScan™W1TR012017-06-18
00643169735644Percepta™ Quad CRT-P MRI SureScan™W4TR012017-06-18
00643169735651Serena™ CRT-P MRI SureScan™W1TR022017-06-18
00643169735668Serena™ Quad CRT-P MRI SureScan™W4TR022017-06-18
00643169735675Solara™ CRT-P MRI SureScan™W1TR032017-06-18
00643169891401Percepta™ CRT-P MRI SureScan™W1TR012017-10-20
00643169891418Percepta™ Quad CRT-P MRI SureScan™W4TR012017-10-20
00643169891425Serena™ CRT-P MRI SureScan™W1TR022017-10-20
00643169891432Serena™ Quad CRT-P MRI SureScan™W4TR022017-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250413406470ABPMpro cuff for right armSOMNOmedics AGDXS2026-07-07
20763000946504DLP®MEDTRONIC, INC.DXS2024-07-18
00763000946500DLP®MEDTRONIC, INC.DXS2024-07-18
20643169880959DLP®MEDTRONIC, INC.DXS2019-03-03
20613994846604DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846642DLP®MEDTRONIC, INC.DXS2016-06-13
20613994846666DLP®MEDTRONIC, INC.DXS2016-06-13
00643169200999NAMEDTRONIC, INC.DXS2016-04-28
B0663014000000PRESSURE GAUGE ISOLATOR KITNOVOSCI CORP.DXS2015-10-09
B0663014000007PRESSURE GUAGE ISOLATOR KITNOVOSCI CORP.DXS2015-10-09