V-Go Disposable Insulin Delivery

Basic Information

• Brand Name: V-Go Disposable Insulin Delivery
• Primary DI: 00385609600012
• Version / Model: V-Go 40
• Catalog Number: 8560-9600-01
• Company Name: MANNKIND CORPORATION
• Labeler DUNS: 099981040
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-05-24
• Public Version: 7
• Public Version Date: 2022-06-30
• Public Version Status: Update
• Public Device Record Key: 037de6e6-2098-4c5f-b182-dc7a7f6bb553

Device Description

40 Units/24 hour basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments

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: No
• 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
51081	Ambulatory insulin infusion pump, mechanical	A portable, mechanical (non-electric) device designed to provide basal and/or periodic bolus 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. The device typically integrates a needle(s)/infusion cannula and an insulin reservoir; it is patient operated (e.g., by squeezing/pressing buttons) and may be daily-disposable or used for several days before being discarded. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10385609600019	GS1	carton	10	In Commercial Distribution
Primary	00385609600012	GS1
Unit of Use	00385600000408	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K103825	000

Device Sizes

Type	Value	Unit	Text
Total Volume	.76	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 140 Degrees Fahrenheit