Truwave

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: TRUWAVE FDA UDI
Generic Name: Luer-formatted protective cap FDA UDI
Device Name: PRESSURE MONITORING ACCESSORY FDA UDI
Model / Reference: MFNVC FDA UDI
Description: PRESSURE MONITORING ACCESSORY FDA UDI

Identifiers

Catalog Number: MFNVC FDA UDI
Primary DI / UDI-DI: 07460691959620 FDA UDI
510(k) Number: K142749 FDA UDI
K171996 FDA UDI
FDA Product Code: DXO FDA UDI
GMDN Term: Luer-formatted protective cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2870 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

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

Category: Invasive-pressure external transducer, single-use Luer-formatted protective cap

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

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Also classified as Luer-formatted protective cap.

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IV Plus® — Nexus Medical, LLC · Class II
Replacement Cap — B. BRAUN MEDICAL INC. · Class II

Cleared under the same submission

K142749 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: Edwards Lifesciences LLC

Sources (1)

FDA UDI bfca758b-7dda-4b88-93ed-cd000b0bc06e 37 fields · synced Jun 8, 2026