Infinity

Basic Information

• Brand Name: Infinity
• Primary DI: 10814844001584
• Version / Model: PCK1001
• Catalog Number: 50745-001
• Company Name: ZEVEX INTERNATIONAL, INC.
• Labeler DUNS: 612746933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-06
• Public Version: 2
• Public Version Date: 2023-04-04
• Public Version Status: Update
• Public Device Record Key: db052a67-002e-49a4-a3bb-67dd02754d0a

Device Description

Enteralite Infinity Mini Backpack, Red

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
LZH	Pump, Infusion, Enteral	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37685	Personal device holder, reusable	A portable device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, or clothing, or as a trolley with wheels. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10814844001584	GS1

Customer Contacts

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