ICU Medical

FDA UDI

Class II (US FDA UDI)

by Icu Medical, Inc.

Identity

Trade Name: ICU Medical FDA UDI
Generic Name: Invasive blood pressure transducer set FDA UDI
Device Name: Transpac™ IV Trifurcated Monitoring Kit w/Safeset™ Reservoir and 2 Blood Sampling Ports, 84", 3 03 ml Squeeze Flush Devices, 3 Disposable Transducers, Macrodrip (Pole Mount) Un-Bonded FDA UDI
Model / Reference: 46115-71 FDA UDI
Description: Transpac™ IV Trifurcated Monitoring Kit w/Safeset™ Reservoir and 2 Blood Sampling Ports, 84", 3 03 ml Squeeze Flush Devices, 3 Disposable Transducers, Macrodrip (Pole Mount) Un-Bonded FDA UDI

Identifiers

Catalog Number: 46115-71 FDA UDI
Primary DI / UDI-DI: 00887709087224 FDA UDI
510(k) Number: K061573 FDA UDI
FDA Product Code: DRS FDA UDI
GMDN Term: Invasive blood pressure transducer set FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

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

Yes

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

Category: Invasive blood pressure transducer set

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

Similar devices

Also classified as Invasive blood pressure transducer set.

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ArgoTrans™ — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Antmed — ShenZhen Antmed Co., Ltd · Class II
BIOTRANS™ Pressure Monitoring Kits — BIOPTIMAL INTERNATIONAL PTE. LTD. · Class II
Monitoring Kit — Argon Medical Devices, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II

Cleared under the same submission

K061573 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 7c4a3f81-3972-43ec-a8e2-6c94bd7788b8 36 fields · synced May 30, 2026