Animas Vibe

Basic Information

• Brand Name: Animas Vibe
• Primary DI: 10840406103137
• Version / Model: 13920000
• Catalog Number: 13920000
• Company Name: ANIMAS CORPORATION
• Labeler DUNS: 968998641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-01-15
• Public Version: 4
• Public Version Date: 2021-08-04
• Public Version Status: Update
• Public Device Record Key: 1d5ab97a-4a16-45bf-a749-31f674f4478a
• Distribution End Date: 2020-07-21

Device Description

Insulin Pump w/o Kit, Refurb, Adult, Black

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: No
• 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
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64891	Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10840406103137	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity