MiniMed® 530G

Basic Information

• Brand Name: MiniMed® 530G
• Primary DI: 00643169507012
• Version / Model: MMT-751LNAB
• Company Name: MEDTRONIC MINIMED, INC.
• Labeler DUNS: 849626338
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-23
• Public Version: 4
• Public Version Date: 2018-09-12
• Public Version Status: Update
• Public Device Record Key: 9af40cb6-9bab-4e03-8250-bdb03c93f03c
• Distribution End Date: 2016-12-15

Device Description

PUMP MMT-751LNAB PRDGM V3.0 BL EN PR LN

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: 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	Artificial pancreas device system, threshold suspend	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35983	Ambulatory insulin infusion pump, electronic	A portable, battery-powered, electronic device designed to provide continuous or intermittent 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. It includes a reservoir (e.g., a cartridge similar to a syringe), a pumping mechanism, and an infusion-rate controller. The pump infuses microvolume pulses and/or bolus doses of insulin subcutaneously, typically into the abdomen, through a needle or catheter (not included).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169507012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P120010	005

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius