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Cadd

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
CADD FDA UDI
Generic Name
Infusion pump medication-dosage application software FDA UDI
Model / Reference
21-6143-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00610586019145 FDA UDI
510(k) Number
K973917 FDA UDI
FDA Product Code
FRN FDA UDI
GMDN Term
Infusion pump medication-dosage application software 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Infusion pump medication-dosage application software

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

Similar devices

Also classified as Infusion pump medication-dosage application software.

Cleared under the same submission

K973917 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icu Medical, Inc.

Sources (1)

  • FDA UDI 7d975fb1-69b3-435a-829b-e1df36c8bd3c 33 fields · synced Jun 1, 2026