statMAP 7200-0001

GUDID 00860498002609

Electronic, hand-held, battery operated blood pressure measurement device.

RAMSEY MEDICAL, INC.

Manual-inflation electronic sphygmomanometer, portable

• Primary Device ID: 00860498002609
• NIH Device Record Key: 06ee9438-0815-4230-9758-05f305a6a294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: statMAP
• Version Model Number: single unit
• Catalog Number: 7200-0001
• Company DUNS: 075865678
• Company Name: RAMSEY MEDICAL, 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 231-6370
• Email: cconley@CardioCommand.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860498002609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072109

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-02-26

On-Brand Devices [statMAP]

• 00860498002616: Re-manufactured electronic, hand-held, battery operated blood pressure measurement device.
• 00860498002609: Electronic, hand-held, battery operated blood pressure measurement device.