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Schiller

FDA UDI

Class II (US FDA UDI)

by Schiller Medical

Identity

Trade Name
SCHILLER FDA UDI
Generic Name
General-purpose patient temperature probe, reusable FDA UDI
Device Name
Optical temperature probe for MAGLIFE Serenity FDA UDI
Model / Reference
Temp. Probe optical skin FDA UDI
Description
Optical temperature probe for MAGLIFE Serenity FDA UDI

Identifiers

Catalog Number
9-01-0187 FDA UDI
Primary DI / UDI-DI
07613365900088 FDA UDI
510(k) Number
K023195 FDA UDI
FDA Product Code
MWI FDA UDI
GMDN Term
General-purpose patient temperature 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: General-purpose patient temperature probe, reusable

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

Similar devices

Also classified as General-purpose patient temperature probe, reusable.

Cleared under the same submission

K023195 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Schiller Medical

Sources (1)

  • FDA UDI 457f21b2-56e8-4563-b050-51fa2728e7f2 36 fields · synced May 30, 2026