Midmark IQvitals® Device Kit with touchscreen - Blood Pressure and Temperature

Basic Information

• Brand Name: Midmark IQvitals® Device Kit with touchscreen - Blood Pressure and Temperature
• Primary DI: 00841709100802
• Version / Model: 4-000-0500
• Catalog Number: 4-000-0500
• 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: 5
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: d8ec7599-dfee-4b2d-87d4-0c051196b577

Device Description

Midmark IQvitals is an affordable, Windows based device that provides automated blood pressure, temperature, and pulse rate readings with a touch of the screen. Kit includes: IQvitals Device w/Blood Pressure and Temperature, AC Power Supply, Reusable Blood Pressure Cuff - Adult, Reusable Blood Pressure Cuff - Large Adult, Blood Pressure Hose - 6.5', Oral/Axillary Temperature Probe, Temperature Probe Covers (box of 20), Serial Cable - 10', and USB Cable - 10'.

Device Characteristics

• Single Use: No
• 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: 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709100802	GS1

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 Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius