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Swan-Ganz

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
SWAN-GANZ FDA UDI
Generic Name
Oximeter catheter, single-use FDA UDI
Device Name
NON-BALLOON DUAL LUMEN OXIMETRY CATHETER FDA UDI
Model / Reference
015F4 FDA UDI
Description
NON-BALLOON DUAL LUMEN OXIMETRY CATHETER FDA UDI

Identifiers

Catalog Number
015F4 FDA UDI
Primary DI / UDI-DI
00690103000207 FDA UDI
510(k) Number
K926450 FDA UDI
FDA Product Code
DQE FDA UDI
GMDN Term
Oximeter catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

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

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Oximeter catheter, single-use

Swan-Ganz 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

K926450 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 c527bf5e-4781-4c8f-8710-ca22e2b55196 38 fields · synced Jun 8, 2026