RENPHO Blood Pressure Monitor

Basic Information

• Brand Name: RENPHO Blood Pressure Monitor
• Primary DI: 04897106770045
• Version / Model: RP-BPM001S
• Company Name: JOICOM CORPORATION
• Labeler DUNS: 081060692
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-06
• Public Version: 1
• Public Version Date: 2020-08-14
• Public Version Status: New
• Public Device Record Key: af1c2cf4-d8a1-494c-809b-81ec9805c91e

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
62805	Transcutaneous central venous pressure sensor	A noninvasive, electronic device intended to transcutaneously detect a patient's central venous pressure (CVP) using light emission/diffusion signals (e.g., near-infrared spectroscopy). It consists of a small photoelectric unit placed on the jugular vein area of the neck, tubing for ambient pressure detection, and a calibration reference. The detected signals correlating to CVP are transmitted to a connected blood pressure monitor (not included) with integrated software for measurement, analysis, and display. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04897106770045	GS1

Premarket Submissions

Submission Number	Supplement Number
K120058	000