Truwave

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 50P106

by Edwards Lifesciences LLC

Identity

Trade Name: TRUWAVE EUDAMEDFDA UDI
Generic Name: Invasive-pressure external transducer, single-use FDA UDI
Device Name: TruWave Pressure Monitoring Kit Additional accessories EUDAMED
PRESSURE TUBING FDA UDI
Model / Reference: 50P106 EUDAMEDFDA UDI
Description: PRESSURE TUBING FDA UDI

Identifiers

Catalog Number: 50P106 FDA UDI
Primary DI / UDI-DI: 07460691951846 EUDAMEDFDA UDI
Basic UDI-DI: 0690103D001TDA000SS EUDAMED
510(k) Number: K142749 FDA UDI
K171996 FDA UDI
FDA Product Code: DXO FDA UDI
EMDN Code: Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
GMDN Term: Invasive-pressure external transducer, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 870.2870 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 6 Inch FDA UDI

Category: Invasive-pressure external transducer, single-use Invasive blood pressure monitoring tubing set

Truwave by Edwards Lifesciences LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Invasive blood pressure monitoring tubing set.

GE Compatible Adult NIBP Hose, 8 ft, Dual, Female Threaded BP09 Connectors — CABLES AND SENSORS, LLC · Class II
EASY VENT(TM) EDE-001 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
NAMIC — NAVILYST MEDICAL, INC. · Class I
CRITIFLO(TM) TA4004 (3ML/HR) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
COMP PRLINE MF 80 IN (200CM) CLR — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
NAMIC — MEDLINE INDUSTRIES, INC. · Class I
Connecting Tube — Tianck Medical Co., Ltd. · Class II
GE Dinamap NIBP Hose: Adult NIBP Hose — CABLES AND SENSORS, LLC · Class II

Cleared under the same submission

K142749 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (2)

FDA UDI 4ccc7b72-6c2b-491d-9854-f1713d3b1a27 38 fields · synced Oct 7, 2026
EUDAMED 6c08b925-dc10-43df-940e-03e302b3bd81 61 fields · synced Oct 7, 2026