DianaTM Automated Drug Compounding System

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: DianaTM Automated Drug Compounding System FDA UDI
Generic Name: Pharmaceutical fluid-dispensing system FDA UDI
Device Name: Diana Automated Drug Compounding System FDA UDI
Model / Reference: CL5000 FDA UDI
Description: Diana Automated Drug Compounding System FDA UDI

Identifiers

Catalog Number: CL5000 FDA UDI
Primary DI / UDI-DI: 00840619090876 FDA UDI
FDA Product Code: NEP FDA UDI
GMDN Term: Pharmaceutical fluid-dispensing system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pharmaceutical fluid-dispensing system

DianaTM Automated Drug Compounding System by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pharmaceutical fluid-dispensing system.

Mixing Tips — Gc America Inc. · Class II
COE® Adhesive — Gc America Inc. · Class II
MULTI-AD® — B. BRAUN MEDICAL INC. · Class I
Mixing Tips — Gc America Inc. · Class II
Mixing Tips — Gc America Inc. · Class II
Mixing Tips — Gc America Inc. · Class II
COE® Adhesive — Gc America Inc. · Class II
APOTECA — AEA SRL · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI f4a220b5-389a-45d0-bb4e-d1f853e47703 35 fields · synced May 30, 2026