Holter Prep Kit

Basic Information

• Brand Name: Holter Prep Kit
• Primary DI: 10812345026020
• Version / Model: XKTHOLT5LA
• Company Name: MORTARA INSTRUMENT, INC.
• Labeler DUNS: 062046149
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 7
• Public Version Date: 2020-07-17
• Public Version Status: Update
• Public Device Record Key: 53ae5108-ee3d-42a2-81b8-d14f6f6eeaa9
• Distribution End Date: 2020-07-16

Device Description

Holter prep kit with AAA battery cleared with H3+ Holter recorder

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWJ	Electrocardiograph,Ambulatory(Without Analysis)	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35162	Electrocardiographic ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30812345026024	GS1		3	Not in Commercial Distribution	2020-07-16
Package	20812345026027	GS1		10	Not in Commercial Distribution	2020-07-16
Primary	10812345026020	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat
• Type: Storage Environment Temperature
• Temperature Range: – 80 Degrees Fahrenheit