Healthcare Access Terminal

Basic Information

• Brand Name: Healthcare Access Terminal
• Primary DI: 00863353000307
• Version / Model: 3.0
• Company Name: BL HEALTHCARE, INC.
• Labeler DUNS: 171081909
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-13
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 662fd37f-e826-461e-9795-440f8fb8e912

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18118	Home healthcare information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of home healthcare services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863353000307	GS1

Premarket Submissions

Submission Number	Supplement Number
K113493	000