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Level 1

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Level 1 FDA UDI
Generic Name
Electromechanical device/system transport trolley FDA UDI
Model / Reference
L1-Cart FDA UDI

Identifiers

Primary DI / UDI-DI
15019517100297 FDA UDI
510(k) Number
K181699 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Electromechanical device/system transport trolley FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 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

No

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

Yes

FDA UDI

Category: Electromechanical device/system transport trolley

Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromechanical device/system transport trolley.

Cleared under the same submission

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 3852d219-2c63-4524-8992-9fe0b2dd8ade 33 fields · synced Jun 6, 2026