Midmark IQholter® Digital Holter Recorder

Basic Information

• Brand Name: Midmark IQholter® Digital Holter Recorder
• Primary DI: 00841709100659
• Version / Model: 1-370-0005
• Catalog Number: 1-370-0005
• 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: 593aa9d2-3c2a-4168-b0bd-4b5b3d6e882f

Device Description

Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	870.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36827	Electrocardiographic long-term ambulatory recording analyser	An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709100659	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.7" x 2.6" x 1.06"; Weight: 2.8 oz. (no battery or SD card)

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 Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 70 Degrees Celsius