Vive Precision

Basic Information

• Brand Name: Vive Precision
• Primary DI: 00810041987587
• Version / Model: DMD1064BLK
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-20
• Public Version: 1
• Public Version Date: 2021-10-28
• Public Version Status: New
• Public Device Record Key: 5647c1b2-520c-42b8-9a92-127b0f528a41

Device Description

Blood Pressure Monitor Model: BT-S

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
31691	Blood pressure alarm	An electronic device that receives signals from a blood pressure sensor and produces a sound and/or visual signal when pre-set upper or lower limits are exceeded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810041987584	GS1	Case	20	In Commercial Distribution
Primary	00810041987587	GS1