MiniMed™ Reservoir

Basic Information

• Brand Name: MiniMed™ Reservoir
• Primary DI: 20763000273334
• Version / Model: MMT-326A
• Company Name: MEDTRONIC MINIMED, INC.
• Labeler DUNS: 849626338
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-09-02
• Public Version: 2
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 6ea6d77b-d58f-49ed-b847-97aaa529633d

Device Description

RSVR MMT-326A 10PK 1.8ML POB PS 21L

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
OZP	Automated insulin dosing device system, single hormonal control	Unknown		3
FRN	Pump, infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35838	Ambulatory insulin infusion pump reservoir	An insulin-filled receptacle (e.g., a cartridge similar to a syringe) intended to be used together with a body-worn insulin pump for the delivery of patient-controlled amounts of insulin to an ambulatory diabetic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20763000273334	GS1
Unit of Use	00763000273330	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001828	000
K032005	000