MiniMed® 630G

Basic Information

• Brand Name: MiniMed® 630G
• Primary DI: 00763000367060
• Version / Model: MMT-1715KR
• Company Name: MEDTRONIC MINIMED, INC.
• Labeler DUNS: 849626338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-16
• Public Version: 2
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: 9945a15e-7d98-4aa2-adac-9d1b9f3dbc1b

Device Description

PUMP MMT-1715KR 630G V4.11 JBL MG RECERT

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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
OZO	Automated insulin dosing , threshold suspend	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64890	Ambulatory insulin infusion pump, electronic, software-dosing, binary 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 pre-set thresholds using a dichotomous or binary 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	00763000367060	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150001	083

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius