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Medline Industries, Inc.

FDA UDI

Class II (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline Industries, Inc. FDA UDI
Generic Name
General surgical procedure kit, medicated FDA UDI
Device Name
OPEN HEART FDA UDI
Model / Reference
CDS982026T FDA UDI
Description
OPEN HEART FDA UDI

Identifiers

Catalog Number
CDS982026T FDA UDI
Primary DI / UDI-DI
10195327000561 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
General surgical procedure kit, medicated 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

No

FDA UDI

Category: General surgical procedure kit, medicated

Medline Industries, Inc.'s OPEN HEART is a comprehensive general surgical procedure kit designed for medical professionals, intended to provide a one-stop solution for various open abdominal and non-orthopaedic trauma surgery procedures. The device is not dedicated to surgical scrubbing or preparation, nor does it include anaesthesia equipment, making it suitable for use in single-use settings.

Similar devices

Also classified as General surgical procedure kit, medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medline Industries, Inc.

Sources (1)

  • FDA UDI 499c45eb-b31f-4a26-bfca-05c9da7f232a 35 fields · synced Oct 6, 2026