← Back to catalogue

Pediasat

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name
PEDIASAT FDA UDI
Generic Name
Oximeter catheter, single-use FDA UDI
Device Name
PEDIASAT OXIMETRY CATHETER SET FDA UDI
Model / Reference
XT245SP FDA UDI
Description
PEDIASAT OXIMETRY CATHETER SET FDA UDI

Identifiers

Catalog Number
XT245SP FDA UDI
Primary DI / UDI-DI
00690103197488 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

Pediasat 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 76a8e5af-c7c8-46b3-b0ec-386ce46ea2d7 38 fields · synced Jun 8, 2026