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Methodist Cardioplegic Admin. Set

FDA UDI

Class II (US FDA UDI)

by Novosci Corp.

Identity

Trade Name
METHODIST CARDIOPLEGIC ADMIN. SET FDA UDI
Generic Name
Cardioplegia solution administration adaptor FDA UDI
Device Name
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. FDA UDI
Model / Reference
411007-000 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
411007-000 FDA UDI
Primary DI / UDI-DI
B0664110070000 FDA UDI
510(k) Number
K802545 FDA UDI
FDA Product Code
DTR FDA UDI
GMDN Term
Cardioplegia solution administration adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4240 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardioplegia solution administration adaptor

Methodist Cardioplegic Admin. Set by Novosci Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardioplegia solution administration adaptor.

Cleared under the same submission

K802545 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novosci Corp.

Sources (1)

  • FDA UDI 10ce4701-daf7-4fe3-9be6-6033ad9468f9 36 fields · synced Jun 1, 2026