NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994521781
• Version / Model: 5441
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• 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: 2019-02-13
• Public Version Status: Update
• Public Device Record Key: fd768079-736a-420a-94cf-1f77950ceed8
• Distribution End Date: 2019-01-25

Device Description

COVER 5441 DISPOSABLE GLBL 3PK PACK

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWP	Implantable pulse generator, pacemaker (non-CRT)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
59447	External pacemaker cover	A non-sterile device, typically made of disposable transparent plastic, intended to be attached over the control panel of a pacemaker external pulse generator (EPG) to form a protective enclosure to help prevent accidental changes to the EPG control settings. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994521781	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P820003	072

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 135 Degrees Fahrenheit