Fetal Monitor Remote Display

Basic Information

• Brand Name: Fetal Monitor Remote Display
• Primary DI: B321340226010
• Version / Model: FMRD 4K 55"
• Catalog Number: 340-22601
• Company Name: CLINICOMP INTERNATIONAL, INC.
• Labeler DUNS: 113412019
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-20
• Public Version: 2
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 0a101920-7296-45cd-a412-25a3b2f59895

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B321340226010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K931133	000

Device Sizes

Type	Value	Unit	Text
Height	28	Inch
Length	49	Inch
Weight	42	Pound

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 35 Degrees Celsius