Life Gift Cardiopelgia Administration Set - A sterile device designed to facilitate/regulate - NOVOSCI CORP.

Duns Number:938289980

Device Description: A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to A 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.

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More Product Details

Catalog Number

411005-000

Brand Name

Life Gift Cardiopelgia Administration Set

Version/Model Number

411005-000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DTR

Product Code Name

Heat-Exchanger, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

699bb5ef-7f2d-44c6-9e60-08aa187c19cd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

B0664110050003

Quantity per Package

10

Contains DI Package

B0664110050000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"NOVOSCI CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50