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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
XT248SP FDA UDI
Description
PEDIASAT OXIMETRY CATHETER SET FDA UDI

Identifiers

Catalog Number
XT248SP FDA UDI
Primary DI / UDI-DI
00690103197518 FDA UDI
510(k) Number
K053609 FDA UDI
K110167 FDA UDI
FDA Product Code
DRE FDA UDI
DQE FDA UDI
DXG FDA UDI
GMDN Term
Oximeter catheter, single-use FDA UDI

Classification

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

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Manufacturer

Manufacturer
Edwards Lifesciences LLC

Sources (1)

  • FDA UDI 18c1b690-8b35-4708-a93e-81b8422e11ad 38 fields · synced Jun 8, 2026