Mannequin™ Endoventricular Shaper

GUDID 00899054002142

Mannequin™ Endoventricular Shaper, 110cc

KDL MEDICAL, INC.

Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00899054002142
• NIH Device Record Key: e6dd0434-9ae6-408e-8af8-751e48e18e24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mannequin™ Endoventricular Shaper
• Version Model Number: VRD-0110S
• Company DUNS: 791048924
• Company Name: KDL MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899054002142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020233

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-05-23

On-Brand Devices [Mannequin™ Endoventricular Shaper]

• 00899054002258: Mannequin™ Endoventricular Shaper, 85cc
• 00899054002241: Mannequin™ Endoventricular Shaper, 150cc
• 00899054002234: Mannequin™ Endoventricular Shaper, 140cc
• 00899054002227: Mannequin™ Endoventricular Shaper, 130cc
• 00899054002197: Mannequin™ Endoventricular Shaper, 120cc
• 00899054002142: Mannequin™ Endoventricular Shaper, 110cc
• 00899054002111: Mannequin™ Endoventricular Shaper, 100cc
• 00899054002098: Mannequin™ Endoventricular Shaper, 90cc
• 00899054002067: Mannequin™ Endoventricular Shaper, 80cc