TruWave

FDA UDI

Class I (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: TruWave FDA UDI
Generic Name: Blood pressure transducer holder FDA UDI
Device Name: PRESSURE MONITORING ACCESSORY FDA UDI
Model / Reference: MP111 FDA UDI
Description: PRESSURE MONITORING ACCESSORY FDA UDI

Identifiers

Catalog Number: MP111 FDA UDI
Primary DI / UDI-DI: 07460691956148 FDA UDI
510(k) Number: K925638 FDA UDI
FDA Product Code: FOX FDA UDI
GMDN Term: Blood pressure transducer holder FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6990 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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: Blood pressure transducer holder

TruWave by Edwards Lifesciences LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K925638 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 I	Pending data

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Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI 36e3c1d5-9eb3-4a8c-85c9-437ef74603fd 37 fields · synced Jun 8, 2026