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
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30
00199150083763NA7J79R92026-05-30
00199150083794NABB8P50R62026-05-30
00199150083800NABB12E50R62026-05-30
00199150083817NABB10Z66R152026-05-30
00199150083893NA7E60R32026-05-30
00199150083985NABB12V61R12026-05-30
00199309002416N/ATH91DBS2026-05-29
00613994964120Sones™ Brachial9907072016-06-05
00613994964748Goodale-Lubin™0074602016-06-05
00199150006038N/ATM91D02026-05-23
00199150080649NABB12S94R52026-05-23
00199150080694NABB12V43R12026-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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