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Truwave

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
TRUWAVE FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
89663300 - CABLE ASSY,EW,BI,PHLPS FDA UDI
Model / Reference
PX1800 FDA UDI
Description
89663300 - CABLE ASSY,EW,BI,PHLPS FDA UDI

Identifiers

Catalog Number
896633008 FDA UDI
Primary DI / UDI-DI
00690103218350 FDA UDI
510(k) Number
K142749 FDA UDI
FDA Product Code
DXO FDA UDI
GMDN Term
General-purpose patient temperature probe, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 162 Inch FDA UDI

Category: General-purpose patient temperature probe, reusable

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

Similar devices

Also classified as General-purpose patient temperature probe, reusable.

Cleared under the same submission

K142749 also covers:

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 d6eea20f-e3a8-4ab4-bba0-0ffa2b2a4c89 38 fields · synced Jun 8, 2026