Cadd

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: CADD FDA UDI
Generic Name: Bedside infusion pump, single-channel FDA UDI
Model / Reference: 21-6300-51 FDA UDI

Identifiers

Primary DI / UDI-DI: 10610586019449 FDA UDI
510(k) Number: K982839 FDA UDI
FDA Product Code: MEA FDA UDI
GMDN Term: Bedside infusion pump, single-channel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bedside infusion pump, single-channel

Cadd by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bedside infusion pump, single-channel.

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Plum — Hospira, Inc. · Class II
BD® Alaris™ PCU Model 8015 — CareFusion 303, INC · Class II
Dispenser DP 30 — Nouvag AG · Class II
MEDRAD® Intego PET Infusion System — Bayer Medical Care Inc. · Class II
Ivenix Infusion System — Fresenius Kabi · Class II

Cleared under the same submission

K982839 also covers:

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

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Manufacturer

Manufacturer: Icu Medical, Inc.

Sources (1)

FDA UDI 8ba984f2-2cc6-40fb-80c2-f7a16ba210a4 33 fields · synced May 30, 2026