Omnipod DASH Pod

Basic Information

• Brand Name: Omnipod DASH Pod
• Primary DI: 10385082000023
• Version / Model: POD-BLE-11-520
• Company Name: INSULET CORPORATION
• Labeler DUNS: 051334402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-01
• Public Version: 2
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: 9c3a70fa-e8a8-4ee0-8c96-000616ba7246

Device Description

DASH Pod

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LZG	Pump, Infusion, Insulin	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35983	Ambulatory insulin infusion pump, electronic	A portable, battery-powered, electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus. It may be badge-like, designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), or worn in a case attached to the belt or carried in a pocket. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20385082000020	GS1	10 Pack Box	10	In Commercial Distribution
Direct Marking	10385082000023	GS1
Primary	10385082000023	GS1
Package	20385082000051	GS1	5 Pack Box	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180045	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 20 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit