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Truwave

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
TRUWAVE FDA UDI
Generic Name
Invasive-pressure external transducer, single-use FDA UDI
Device Name
PRESSURE MONITORING SET FDA UDI
Model / Reference
T001789B FDA UDI
Description
PRESSURE MONITORING SET FDA UDI

Identifiers

Catalog Number
T001789B FDA UDI
Primary DI / UDI-DI
07460691948334 FDA UDI
FDA Product Code
DXO FDA UDI
GMDN Term
Invasive-pressure external transducer, single-use 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Invasive-pressure external transducer, single-use

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

Similar devices

Also classified as Invasive-pressure external transducer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI aaca28d0-359c-431d-bee9-3532be3220b6 37 fields · synced Jun 8, 2026