Omnipod 5 Controller

Basic Information

• Brand Name: Omnipod 5 Controller
• Primary DI: 10385083000022
• Version / Model: PDM-H001-G-XX
• Catalog Number: SKT-H001-G-X9
• Company Name: INSULET CORPORATION
• Labeler DUNS: 051334402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-25
• Public Version: 2
• Public Version Date: 2022-12-26
• Public Version Status: Update
• Public Device Record Key: d044bf69-33ef-48de-bb48-ea2edce1eac6

Device Description

Omnipod 5 Controller (PDM) mg/dl - English with PodPals

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFG	Alternate Controller Enabled Insulin Infusion Pump	Clinical Chemistry	880.5730	2
QJI	Interoperable Automated Glycemic Controller	Clinical Chemistry	862.1356	2
QRX	Continuous Glucose Monitor Informed Insulin Dose Calculator	Clinical Chemistry	862.1358	2
NDC	Calculator, Drug Dose	Anesthesiology	868.1890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60770	Ambulatory insulin infusion pump/interstitial glucose monitoring system	An assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10385083000022	GS1
Package	30385083000019	GS1	Starter Kit w/ Pals	1	In Commercial Distribution
Package	30385083000095	GS1	Starter Kit w/o Pals	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal