AccessGUDID - DEVICE: MMI App for iOS (00850037806010)

GUDID

Device Identifier (DI) Information

Brand Name: MMI App for iOS
Version or Model: MODD1 Insulin Delivery System
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MTL-103
Company Name: Modular Medical, Inc.

Primary DI Number: 00850037806010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 602638525 *Terms of Use

Device Description: iOS smartphone application for MODD1 Insulin Delivery System, software version v1.X

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?
64648	Ambulatory insulin infusion pump software, patient-dosing	A software application intended to allow a patient to remotely control the functions of an electronic ambulatory insulin infusion pump or pump/administration unit (e.g., pharmaceutical delivery, dosage settings), and typically also extract data from the pump. It is intended to be used on a non-medical computerized device (e.g., smartphone) and may transmit data to other platforms for recording/analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240158	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: 08550141-8740-4dd4-91b0-e486f3a077ce
Public Version Date: July 21, 2025
Public Version Number: 1
DI Record Publish Date: July 11, 2025