← Back to catalogue

Cardinal Health

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
CV OPEN HEART PACK FDA UDI
Model / Reference
SCV44OHUTA FDA UDI
Description
CV OPEN HEART PACK FDA UDI

Identifiers

Catalog Number
SCV44OHUTA FDA UDI
Primary DI / UDI-DI
10888439400656 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Cardiothoracic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiothoracic surgical procedure kit, non-medicated, single-use

A comprehensive cardiovascular procedure kit designed for use during cardiothoracic surgery, providing a sterile collection of various surgical instruments and materials.

Similar devices

Also classified as Cardiothoracic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI 9c0dcaa2-0413-4130-9545-d34b6abdf7f4 34 fields · synced Oct 6, 2026