BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

Reveal LINQ™ Insertion Tools

DI: 00643169508262 · Model: LNQTOOL · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Reveal LINQ™ Insertion Tools
Primary DI: 00643169508262
Version / Model: LNQTOOL
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-06-10
Public Version: 5
Public Version Date: 2020-01-09
Public Version Status: Update
Public Device Record Key: ee75d55e-165c-4ba6-9b98-8e643c22aea6

Device Description

ACC KIT LNQTOOL TOOLS USA

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
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47804	Implantable cardiac monitor	A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169508262	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132649	000

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 0 – 131 Degrees Fahrenheit
Type: Storage Environment Temperature
Temperature Range: 41 – 104 Degrees Fahrenheit