FDA.reportPublic FDA data

DLP®

Primary DI
20613994619710
Brand
DLP®
Company
MEDTRONIC, INC.
Model
14000
Device description
ADAPTER 14000 MULTIPLE PERF SET 10PK 17L
Published
2016-05-22
Public version status
Update
Distribution status
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass
FMHCONTAINER, SPECIMEN, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2
FMHContainer, Specimen, SterilePathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K791498000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K791498000ADAPTER-Y TYPE/CORONARY PERFUSIONDlp, Inc.1979-08-28DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613994619710PrimaryGS10
00613994619716Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061399461971020613994619710
00613994619716006139946197166139946197160613994619716

GMDN Terms#

Term, Definition table
TermDefinition
Cardioplegia solution administration adaptorA sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length38.1Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
006261481
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846005445NA12T76R12026-07-30
00824846005469NABB2Q31R112026-07-30
00824846005667NABB9R33R162026-07-30
00824846006022NABB12S36R2026-07-30
00824846007944NABB12W03R12026-07-30
00613994746627ATTAIN SELECT™ II624890D022016-07-16
00763000862336MyCareLink™249552026-07-26
00763000060374LINQ II™LNQ222020-07-18
00763000422615SYNCHROMED®II8637-402021-04-11
00763000634094SYNCHROMED® II8637-202022-08-11
00763000634100SYNCHROMED® II8637-402022-08-11
00643169508149SYNCHROMED® II8637-202016-04-27
00643169508156SYNCHROMED® II8637-402016-04-27
00643169630505SYNCHROMED® II8637-202018-08-17
00643169630512SYNCHROMED® II8637-402018-08-17
00643169100824SYNCHROMED ® II8637-402016-04-27
00643169100831SYNCHROMED ® II8637-202016-04-27
00199150084036MiniMed Flex Starter KitMMT-8076B2026-07-19
00199150084043MiniMed Flex Starter KitMMT-8076C2026-07-19
00199150084050MiniMed Extended Supply KitMMT-445B2026-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450795705Merit Medical®Merit Medical Systems, Inc.DTL2026-07-21
10192253051575PrecisionCardinal Health 200, LLCFMH2026-07-09
09555240406361Cell Culture Sampler Wide Cap 2mLITL ASIA PACIFIC SDN. BHD.FMH2026-06-23
00879123009012BFlex™Verathon Medical (Canada) ULCFMH2026-05-29
H1084306551CorningCorning IncorporatedFMH2026-01-26
H1083540141Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540171Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H1083540201Falcon A Corning BrandCorning IncorporatedFMH2026-01-23
H108117391CorningCorning IncorporatedFMH2026-01-14
H108117041CorningCorning IncorporatedFMH2025-10-28
H1084313371CorningCorning IncorporatedFMH2024-10-29
H1084313381CorningCorning IncorporatedFMH2024-10-29
H1084313471CorningCorning IncorporatedFMH2024-10-29
H1084316231CorningCorning IncorporatedFMH2024-10-29
H1084316241CorningCorning IncorporatedFMH2024-10-29
H1084316251CorningCorning IncorporatedFMH2024-10-29
H108117531CorningCorning IncorporatedFMH2022-03-15
H108117541CorningCorning IncorporatedFMH2022-03-15
H108112601CorningCorning IncorporatedFMH2020-12-02
H108117011CorningCorning IncorporatedFMH2020-12-02
H108117021CorningCorning IncorporatedFMH2020-12-02
H108117051CorningCorning IncorporatedFMH2020-12-02
H108117061CorningCorning IncorporatedFMH2020-12-02
H108117501CorningCorning IncorporatedFMH2020-12-02
H10820281Corning®Corning IncorporatedFMH2020-12-02
H1083520011Falcon A Corning BrandCorning IncorporatedFMH2020-12-02
H1083520031Falcon A Corning BrandCorning IncorporatedFMH2020-12-02
H1083520061Falcon A Corning BrandCorning IncorporatedFMH2020-12-02
H1083520371Falcon A Corning BrandCorning IncorporatedFMH2020-12-02
H1083520451Falcon A Corning BrandCorning IncorporatedFMH2020-12-02