AccessGUDID - DEVICE: Omnipod Go Insulin Delivery Device 10U/day POD (10385084000106)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipod Go Insulin Delivery Device 10U/day POD
Version or Model: POD-INS-I1-1025
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Insulet Corporation

Primary DI Number: 10385084000106
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 10U/day POD

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: dbe0510e-0321-44d8-8123-cf0a02524ced
Public Version Date: July 29, 2024
Public Version Number: 2
DI Record Publish Date: August 18, 2023