ENLiTE™

Basic Information

• Brand Name: ENLiTE™
• Primary DI: 00643169455535
• Version / Model: MMT-7008B
• Company Name: MEDTRONIC MINIMED, INC.
• Labeler DUNS: 849626338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-20
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 372ffaed-4379-437d-a158-46f8cb04bf81

Device Description

SENSOR MMT-7008B ENLITE NFIN 2L PLUS

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZO	Automated insulin dosing , threshold suspend	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59016	Percutaneous interstitial-fluid glucose monitoring system needle electrode	An electrical conductor intended to be inserted percutaneously into interstitial tissue to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is typically a thin, flexible, needle electrode that uses electrochemical means to convert glucose levels into an electrical signal. It typically has an adhesive covering that holds it to the skin surface, and transmits the signal via a cable or transmitter. This is a single-patient device intended be used for a period before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169455535	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150001	007

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius