AccessGUDID - DEVICE: Eversense 365 Smart Transmitter Kit (Retail) (00817491024244)

GUDID

Device Identifier (DI) Information

Brand Name: Eversense 365 Smart Transmitter Kit (Retail)
Version or Model: FG-4001-01-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FG-4001-01-001
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491024244
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Eversense 365 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, instructions for use, and a wallet card.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61912	Implantable glucose monitoring system transmitter	A body-worn, battery-powered component of an implantable glucose monitoring system designed to wirelessly transmit glucose measurements continuously from the implanted sensor to a receiver (e.g., a mobile device). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
SBA	Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241335	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
Storage Environment Temperature: between 32 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 745ea9b0-2677-4001-8374-01a8cbb6705c
Public Version Date: October 01, 2024
Public Version Number: 1
DI Record Publish Date: September 23, 2024