Medex

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: Medex FDA UDI
Generic Name: Pressure transducer dome, single-use FDA UDI
Model / Reference: M20770R1 FDA UDI

Identifiers

Primary DI / UDI-DI: 10351688510655 FDA UDI
510(k) Number: K790314 FDA UDI
K820355 FDA UDI
K943897 FDA UDI
FDA Product Code: FPA FDA UDI
FPB FDA UDI
DRS FDA UDI
GMDN Term: Pressure transducer dome, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5440 FDA UDI
870.2850 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Pressure transducer dome, single-use

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

Similar devices

Also classified as Pressure transducer dome, single-use.

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CRITIFLO(TM) TA1017SM (3ML/HR) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
Pressure dome - 30034 — Memscap AS · Class II
SAK1560T — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
TRUWAVE — Edwards Lifesciences LLC · Class II
CRITIFLO(TM) TA1018 (30ML/HR) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II

Cleared under the same submission

K790314 also covers:

K820355 also covers:

K943897 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 685adaed-9319-4625-beb1-388f1e3d075e 33 fields · synced May 29, 2026