FDA.reportPublic FDA data

Mannequin™ Endoventricular Shaper

Primary DI
00899054002241
Brand
Mannequin™ Endoventricular Shaper
Company
KDL MEDICAL, INC.
Model
VRD-0150S
Device description
Mannequin™ Endoventricular Shaper, 150cc
Published
2017-05-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00899054002241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00899054002241008990540022418990540022410899054002241

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.

Regulatory Flags#

DUNS number
791048924
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00899054002067Mannequin™ Endoventricular ShaperVRD-0080S2017-05-23
00899054002098Mannequin™ Endoventricular ShaperVRD-0090S2017-05-23
00899054002111Mannequin™ Endoventricular ShaperVRD-0100S2017-05-23
00899054002142Mannequin™ Endoventricular ShaperVRD-0110S2017-05-23
00899054002166SVR System without PatchSVC-0080S2017-05-23
00899054002197Mannequin™ Endoventricular ShaperVRD-0120S2017-05-23
00899054002227Mannequin™ Endoventricular ShaperVRD-0130S2017-05-23
00899054002234Mannequin™ Endoventricular ShaperVRD-0140S2017-05-23
00899054002258Mannequin™ Endoventricular ShaperVRD-0085S2017-05-23
00899054002326SVR System without PatchSVC-0085S2017-05-23
00899054002333SVR System without PatchSVC-0090S2017-05-23
00899054002340SVR System without PatchSVC-0100S2017-05-23
00899054002357SVR System without PatchSVC-0110S2017-05-23
00899054002364SVR System without PatchSVC-0120S2017-05-23
00899054002371SVR System without PatchSVC-0130S2017-05-23
00899054002388SVR System without PatchSVC-0140S2017-05-23
00899054002395SVR System without PatchSVC-0150S2017-05-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
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14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
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14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646798DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646804DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
00859389005102Tyke, Patch, Pledget and IntracardiacElutia Med LLCDXZ2019-02-28
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14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638663DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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