Fetal Monitor Remote Display

GUDID B321598226000

CLINICOMP INTERNATIONAL, INC.

Patient monitoring system central station monitor Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: B321598226000
• NIH Device Record Key: e1f3126e-139f-413c-9a74-9a880f522dc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fetal Monitor Remote Display
• Version Model Number: 4K 55
• Company DUNS: 113412019
• Company Name: CLINICOMP INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003508202
• Email: radine.pobuda@clinicomp.com
• Phone: 8003508202
• Email: radine.pobuda@clinicomp.com
• Phone: 8003508202
• Email: radine.pobuda@clinicomp.com
• Phone: 8003508202
• Email: radine.pobuda@clinicomp.com
• Phone: 8003508202
• Email: radine.pobuda@clinicomp.com

Device Dimensions

• Weight: 1.5 Pound
• Height: 1.25 Inch
• Depth: 4.25 Inch
• Width: 4.5 Inch
• Weight: 1.5 Pound
• Height: 1.25 Inch
• Depth: 4.25 Inch
• Width: 4.5 Inch
• Weight: 1.5 Pound
• Height: 1.25 Inch
• Depth: 4.25 Inch
• Width: 4.5 Inch
• Weight: 1.5 Pound
• Height: 1.25 Inch
• Depth: 4.25 Inch
• Width: 4.5 Inch
• Weight: 1.5 Pound
• Height: 1.25 Inch
• Depth: 4.25 Inch
• Width: 4.5 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B321598226000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931133

FDA Product Code

• HGM: System, Monitoring, Perinatal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-11

On-Brand Devices [Fetal Monitor Remote Display]

• B321600226100010: 27 Wall Mount
• B321600226100: 27 DeskTop
• B321600226000010: 27 Wall Mount
• B321600226000: 27 DeskTop
• B321600225000010: 27 Wall Mount
• B321600225000: 27 DeskTop
• B321598226000: 4K 55
• B321598225010: 4K 55
• B321598223020: t5745
• B321598223010: t5545
• B321598221010020: ETCX X98-1 (CM9)
• B32160022611001: 27" Wall Mount
• B32159822601: NUC8i3BEK
• B32160022611: 27" DeskTop
• B321598226010: NUC8i3BEK
• B321600226110: 27" DeskTop
• B321600226110010: 27" Wall Mount
• B321340226010: FMRD 4K 55"