AccessGUDID - DEVICE: Omnipod Go Insulin Delivery Device 40U/day (10385084000403)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipod Go Insulin Delivery Device 40U/day
Version or Model: POD-INS-I1-4025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Insulet Corporation

Primary DI Number: 10385084000403
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051334402 *Terms of Use

Device Description: Omnipod Go Insulin Delivery Device 40U/day

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
63803	Ambulatory insulin infusion pump/administration unit	A badge-like, battery-powered, disposable device designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive) to provide basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. The device integrates an electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle; it is patient operated with the use of integral controls or a remote control unit (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	Pump, Infusion, Insulin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223372	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 32 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 20 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a9266d86-bbd4-4fc4-8a05-759fd07ccc45
Public Version Date: July 29, 2024
Public Version Number: 2
DI Record Publish Date: August 18, 2023