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Medex

FDA UDI

Class I (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name
Medex FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Model / Reference
MX9543 FDA UDI

Identifiers

Primary DI / UDI-DI
10351688503091 FDA UDI
510(k) Number
K070340 FDA UDI
K942377 FDA UDI
FDA Product Code
CBT FDA UDI
DPT FDA UDI
GMDN Term
Invasive-pressure external transducer, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.1100 FDA UDI
870.2120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Invasive-pressure external transducer, single-use

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

Similar devices

Also classified as Invasive-pressure external transducer, single-use.

Cleared under the same submission

K070340 also covers:

K942377 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 08894a89-8322-4b94-8f7f-72ceb00f2bbe 33 fields · synced May 30, 2026