Truwave

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: TRUWAVE FDA UDI
Generic Name: Invasive blood pressure monitoring tubing set FDA UDI
Device Name: PRESSURE MONITORING SET FDA UDI
Model / Reference: K16912A FDA UDI
Description: PRESSURE MONITORING SET FDA UDI

Identifiers

Catalog Number: K16912A FDA UDI
Primary DI / UDI-DI: 07460691950382 FDA UDI
510(k) Number: K142749 FDA UDI
K171996 FDA UDI
FDA Product Code: DXO FDA UDI
GMDN Term: Invasive blood pressure monitoring tubing set 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

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

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 12 Inch FDA UDI

Category: Invasive blood pressure monitoring tubing set

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

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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 bac95faf-307f-49a3-b963-ffb19516ffc9 38 fields · synced Jun 8, 2026