Universal Data Acquisition System

GUDID B321598107300

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: B321598107300
• NIH Device Record Key: 5fbaac02-1929-4b73-9c2d-969440be2280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Data Acquisition System
• Version Model Number: UDAS17
• 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: 1.13 Pound
• Depth: 1.875 Inch
• Height: 4.5 Inch
• Width: 8.25 Inch
• Weight: 1.13 Pound
• Depth: 1.875 Inch
• Height: 4.5 Inch
• Width: 8.25 Inch
• Weight: 1.13 Pound
• Depth: 1.875 Inch
• Height: 4.5 Inch
• Width: 8.25 Inch
• Weight: 1.13 Pound
• Depth: 1.875 Inch
• Height: 4.5 Inch
• Width: 8.25 Inch
• Weight: 1.13 Pound
• Depth: 1.875 Inch
• Height: 4.5 Inch
• Width: 8.25 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	B321598107300 [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: 2017-07-26

Devices Manufactured by CLINICOMP INTERNATIONAL, INC.

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• B321598226010 - Fetal Monitor Remote Display: 2019-12-19
• B32160022611 - Fetal Monitor Remote Display: 2019-10-31
• B32159822601 - Fetal Monitor Remote Display: 2019-10-10
• B32160022611001 - Fetal Monitor Remote Display: 2019-10-07
• B321598107300 - Universal Data Acquisition System: 2018-07-06
• B321598107300 - Universal Data Acquisition System: 2018-07-06