BP+ U10200

GUDID 09351405001019

Central Blood Pressure Device

USCOM LIMITED

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 09351405001019
• NIH Device Record Key: 1cbc3aec-e11a-4e8c-a65b-f480157103e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BP+
• Version Model Number: BPPLUS-R7
• Catalog Number: U10200
• Company DUNS: 758363477
• Company Name: USCOM LIMITED
• 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: +61292474144
• Email: info@uscom.com.au

Device Dimensions

• Height: 156 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351405001019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121266

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: 2018-08-08