FDA.reportPublic FDA data

Mannequin™ Endoventricular Shaper

Primary DI
00899054002067
Brand
Mannequin™ Endoventricular Shaper
Company
KDL MEDICAL, INC.
Model
VRD-0080S
Device description
Mannequin™ Endoventricular Shaper, 80cc
Published
2017-05-23
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

Product Codes#

Code, Name table
CodeName
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020233000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020233000CHASE CARDIOVASCULAR PATCH KITChase Medical, Inc.2002-03-14DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00899054002067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002067008990540020678990540020670899054002067

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791048924
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002821Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
00899054002838Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
00899054002845Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
00899054002852Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002647Cobra Surgical Arm, 16cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90162025-02-10
00899054002654Cobra Surgical Arm, 19cm Length, Lg/Med/Sm Links, Shaft ConnectRSA-90192025-02-10
00899054002661Valve Assist Blade, Reusable, Stainless Steel, 11mm x 26mmRAA-911262025-02-10
00899054002678Valve Assist Blade, Reusable, Stainless Steel, 15mm x 26mmRAA-915262025-02-10
00899054002685Valve Assist Blade, Reusable, Stainless Steel, 18mm x 26mmRAA-918262025-02-10
00899054002692Atrial Rake, Reusable, Stainless Steel, 19mm x 24mmRAR-919242025-02-10
00899054002708Atrial Rake, Reusable, Stainless Steel, 19mm x 24mm, Knurled, LongRAR-91924L2025-02-10
00899054002715Atrial Rake, Reusable, Stainless Steel, 29mm x 30mmRAR-929302025-02-10
00899054002722Atrial Rake, Reusable, Stainless Steel, 39mm x 34mmRAR-939342025-02-10
00899054002739Atrial Rake, Reusable, Stainless Steel, 37mm x46mmRAR-939442025-02-10
00899054002814Cobra Surgical Arm, 19cm Length, All Sm Links, Shaft ConnectRSA-91192025-02-10
10899054002828Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm LHAF-2SHS2025-02-10
10899054002835Heart Assist, Single Use, 2 Finger Long, Malleable 36mm W X 90mm LHAF-2LGS2025-02-10
10899054002842Heart Assist, Single Use, 3 Finger Short, Malleable 60mm W X 54mm LHAF-3SHS2025-02-10
10899054002859Heart Assist, Single Use, 3 Finger Long, Malleable 60mm W X 90mm LHAF-3LGS2025-02-10
00899054002203Triumph Aortic Perfusion CannulaMPH-0022S2017-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
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10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
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10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
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