AccessGUDID - DEVICE: Sen-Serter© (00643169164413)

GUDID

Device Identifier (DI) Information

Brand Name: Sen-Serter©
Version or Model: MMT-7500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 00643169164413
Issuing Agency: GS1
Commercial Distribution End Date: April 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: LANCET DEVICE MMT-7500 SENSERTER 21L

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
45449	Injector reset device	A device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDS	Sensor, glucose, invasive
OZO	Artificial pancreas device system, threshold suspend

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980022	171

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: 52b20b84-0ccd-474a-bf75-0d76bce9957b
Public Version Date: April 21, 2025
Public Version Number: 4
DI Record Publish Date: October 01, 2016