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Schiller

FDA UDIEUDAMED

Class II (US FDA UDI)

by Schiller Medical

Identity

Trade Name
SCHILLER FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
SpO2 Adult sensor for MAGLIFE Serenity FDA UDI
Model / Reference
SpO2 sensor Adult FDA UDI
Description
SpO2 Adult sensor for MAGLIFE Serenity FDA UDI

Identifiers

Catalog Number
0-13-0038 FDA UDI
Primary DI / UDI-DI
07613365900040 FDA UDI
510(k) Number
K023195 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2300 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

Schiller by Schiller Medical — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K023195 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Schiller Medical

Sources (2)

  • FDA UDI 1490b6e2-d14c-4cc3-88e2-ee68cc7c7054 36 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 28, 2026