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Edwards Oximetry Central Venous Catheter

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER FDA UDI
Generic Name
Oximeter catheter, single-use FDA UDI
Device Name
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER FDA UDI
Model / Reference
X3820ST FDA UDI
Description
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER FDA UDI

Identifiers

Catalog Number
X3820ST FDA UDI
Primary DI / UDI-DI
00690103197587 FDA UDI
510(k) Number
K053609 FDA UDI
K110167 FDA UDI
FDA Product Code
DXG FDA UDI
DRE FDA UDI
DQE FDA UDI
GMDN Term
Oximeter catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1435 FDA UDI
870.1310 FDA UDI
870.1230 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 Safe FDA UDI

Category: Oximeter catheter, single-use

Edwards Oximetry Central Venous Catheter by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oximeter catheter, single-use.

Cleared under the same submission

K053609 also covers:

K110167 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 43a56e38-1b2f-4384-ad17-9c6464277185 38 fields · synced Jun 8, 2026