Mediblu

Basic Information

• Brand Name: Mediblu
• Primary DI: B632MDB01024
• Version / Model: HP50P
• Catalog Number: MDB01024
• Company Name: MEDIBLU MEDICAL LLC
• Labeler DUNS: 117518078
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-25
• Public Version: 1
• Public Version Date: 2020-07-03
• Public Version Status: New
• Public Device Record Key: 548aee0b-36eb-4fc4-af1a-bd83a2b18a77

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
DXN	System, measurement, blood-pressure, non-invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64510	Arrythmia-detection blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for the 24-hour recording of blood pressure and detection of cardiac arrythmias [e.g., atrial fibrillation (AF)]; it may in addition measure the heart rate and mean arterial pressure. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer or mobile phone with a dedicated software. The device typically incorporates a display and controls, and may include a blood pressure cuff with connection tubing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B632MDB01024	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]