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TempShield

FDA UDI

Class II (US FDA UDI)

by Aion Biosystems, Inc.

Identity

Trade Name
TempShield FDA UDI
Generic Name
Wireless patient thermometer, single-use FDA UDI
Device Name
The TempShield is a wearable device that senses body temperature and communicates with an app on your smartphone. When the TempShield is connected to your device, it sends all temperature measurements automatically. You can wear an TempShield for up to 60 days and check your current temperature and temperature measurements history at any time. You have the ability to share the data with your clinician if your clinician has established an AION account. FDA UDI
Model / Reference
DWF-1824 FDA UDI
Description
The TempShield is a wearable device that senses body temperature and communicates with an app on your smartphone. When the TempShield is connected to your device, it sends all temperature measurements automatically. You can wear an TempShield for up to 60 days and check your current temperature and temperature measurements history at any time. You have the ability to share the data with your clinician if your clinician has established an AION account. FDA UDI

Identifiers

Primary DI / UDI-DI
00197644811199 FDA UDI
510(k) Number
K232010 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Wireless patient thermometer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Wireless patient thermometer, single-use

TempShield by Aion Biosystems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wireless patient thermometer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aion Biosystems, Inc.

Sources (1)

  • FDA UDI c1d46e57-d755-4f8a-bc51-d9ab91381f1e 34 fields · synced Jun 8, 2026