AccessGUDID - DEVICE: Pouch Containing Grafted Sensor and Holder, Eversense 365 (00817491024220)

GUDID

Device Identifier (DI) Information

Brand Name: Pouch Containing Grafted Sensor and Holder, Eversense 365
Version or Model: 102606-023
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SENSEONICS, INCORPORATED

Primary DI Number: 00817491024220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 966865636 *Terms of Use

Device Description: Pouch contains one Eversense 365 Sensor in a Sensor holder.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
61930	Implantable glucose monitoring system sensor	A sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included.	Active	true

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 36 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3ed9a38e-e30a-44ab-8294-6b9382ce57f2
Public Version Date: October 01, 2024
Public Version Number: 1
DI Record Publish Date: September 23, 2024