Healthcare Access Terminal

GUDID 00863353000307

BL HEALTHCARE, INC.

Home healthcare information system

• Primary Device ID: 00863353000307
• NIH Device Record Key: 662fd37f-e826-461e-9795-440f8fb8e912
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healthcare Access Terminal
• Version Model Number: 3.0
• Company DUNS: 171081909
• Company Name: BL HEALTHCARE, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863353000307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113493

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-13

Devices Manufactured by BL HEALTHCARE, INC.

• 00863353000314 - BL Healthcare Blood Pressure Meter: 2019-11-08
• 00863353000307 - Healthcare Access Terminal: 2018-07-06
• 00863353000307 - Healthcare Access Terminal: 2018-07-06
• 00863353000321 - BL Healthcare Bluetooth Weight Scale: 2018-03-29
• 00863353000338 - BL Healthcare Thermometer: 2018-03-29