Standard VAVD Kit H-1136

GUDID B066H11363

A collection of sterile devices intended to be used to inject cardioplegia solution into the heart to interrupt its contractions during cardiopulmonar

NOVOSCI CORP.

Cardioplegia solution administration kit

• Primary Device ID: B066H11363
• NIH Device Record Key: b75084fa-1ccc-4e18-b258-6149fefc6c3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard VAVD Kit
• Version Model Number: H-1136
• Catalog Number: H-1136
• Company DUNS: 938289980
• Company Name: NOVOSCI CORP.
• 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: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B066H11360 [Primary]
HIBCC	B066H11363 [Package]; Contains: B066H11360; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990514

FDA Product Code

• DTP: Defoamer, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

On-Brand Devices [Standard VAVD Kit]

• B066H11363: A collection of sterile devices intended to be used to inject cardioplegia solution into the hea
• B066H11360: A collection of sterile devices intended to be used to inject cardioplegia solution into the hea