BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Extended™ Reservoir

DI: 00763000837235 · Model: MMT-342G · MEDTRONIC MINIMED, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: Extended™ Reservoir
Primary DI: 00763000837235
Version / Model: MMT-342G
Company Name: MEDTRONIC MINIMED, INC.
Labeler DUNS: 849626338
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2024-02-12
Public Version: 1
Public Version Date: 2024-02-20
Public Version Status: New
Public Device Record Key: 5bc5c9e4-e18a-4da4-b469-b8977b43caf3

Device Description

RSVR MMT-342G 5PK EW 3ML US

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
LZP	AID, SURGICAL, VISCOELASTIC	Ophthalmic	886.4275	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000837239	GS1	PK	5	In Commercial Distribution
Primary	00763000837235	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210714	000

Storage Conditions

Type: Storage Environment Humidity
Temperature Range: 0 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -20 – 50 Degrees Celsius