Prep Kit - Midmark IQholter, 7-lead

Basic Information

• Brand Name: Prep Kit - Midmark IQholter, 7-lead
• Primary DI: 00841709100703
• Version / Model: 2-100-0090
• Catalog Number: 2-100-0090
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 73e8c707-a9aa-4e20-94ac-d43aa17512bc

Device Description

These kits are designed to provide the supplies you need for Holter testing. Kit includes: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and seven electrodes.

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62149	Electrocardiographic long-term ambulatory recording support kit	A collection of non-sterile, noninvasive devices intended to be used in conjunction with an electrocardiographic (ECG) long-term ambulatory recorder (holter monitor) to facilitate recording. It includes an ECG electrode(s), batteries (to power the recorder), devices intended to assist electrode application (e.g., razor, electrode placement guide, conductive gel, skin cleaning wipe, tape), and may include other patient-supportive devices (e.g., diary/notebook); the recorder is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709100703	GS1
Package	10841709100700	GS1	Case	30	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.
• Type: Handling Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius