AccessGUDID - DEVICE: Omnipod (Dash) Display App. (10385081120265)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipod (Dash) Display App.
Version or Model: 1.3.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18239
Company Name: Insulet Corporation

Primary DI Number: 10385081120265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051334402 *Terms of Use

Device Description: Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252

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):	No
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?
64656	Ambulatory insulin infusion pump software, data-display	A software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be used on a non-medical computerized device (e.g., smartphone).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKU	Insulin Pump Secondary Display

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 2f4cb276-8c75-4958-880a-83cc0bcd4460
Public Version Date: July 29, 2024
Public Version Number: 3
DI Record Publish Date: February 20, 2021