AccessGUDID - DEVICE: TempShield (00197644811199)

GUDID

Device Identifier (DI) Information

Brand Name: TempShield
Version or Model: DWF-1824
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aion Biosystems, Inc.

Primary DI Number: 00197644811199
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118340537 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62170	Wireless patient thermometer, single-use	A battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit), and is typically used to monitor a fever during daily activities and sleep. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232010	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1d46e57-d755-4f8a-bc51-d9ab91381f1e
Public Version Date: September 24, 2024
Public Version Number: 1
DI Record Publish Date: September 16, 2024