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Co-Set+

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
CO-SET+ FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
INJECTATE TEMPERATURE PROBE FDA UDI
Model / Reference
9850A FDA UDI
Description
INJECTATE TEMPERATURE PROBE FDA UDI

Identifiers

Catalog Number
9850A FDA UDI
Primary DI / UDI-DI
00690103004250 FDA UDI
510(k) Number
K043103 FDA UDI
FDA Product Code
DXG FDA UDI
GMDN Term
General-purpose patient temperature probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1435 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 120 Inch FDA UDI

Category: General-purpose patient temperature probe, reusable

Co-Set+ 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

K043103 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 de7faecb-e078-42b0-b1cd-d2dbf1e42fca 38 fields · synced Jun 8, 2026