Combo Kit

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: Combo Kit FDA UDI
Generic Name: Invasive-pressure external transducer, single-use FDA UDI
Device Name: Pressure Monitoring Set FDA UDI
Model / Reference: PXAVMPL FDA UDI
Description: Pressure Monitoring Set FDA UDI

Identifiers

Catalog Number: PXAVMPL FDA UDI
Primary DI / UDI-DI: 00690103200300 FDA UDI
510(k) Number: K141495 FDA UDI
K142749 FDA UDI
K161962 FDA UDI
FDA Product Code: DXO FDA UDI
KRA 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
870.1210 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

MRI Safety

MR Conditional FDA UDI

Category: Invasive-pressure external transducer, single-use Arterial blood sampling kit

Combo Kit 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 95dd98ad-eb11-4402-b048-16143a56afde 38 fields · synced Jun 8, 2026