AccessGUDID - DEVICE: InPen Smart Insulin Delivery System (00763000489953)

GUDID

Device Identifier (DI) Information

Brand Name: InPen Smart Insulin Delivery System
Version or Model: MMT-8060
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC MINIMED, INC.

Primary DI Number: 00763000489953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 849626338 *Terms of Use

Device Description: SOFTWARE MMT-8060 INSULIN PEN IOS APP

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?
45771	Empty self-injector, mechanical	A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NDC	Calculator, drug dose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190487	000
K242775	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: 6daa4c27-fb3c-4a06-830f-21659f0411fe
Public Version Date: April 01, 2025
Public Version Number: 2
DI Record Publish Date: March 08, 2025