LotFancy

Basic Information

• Brand Name: LotFancy
• Primary DI: 04710953420768
• Version / Model: 11C-1863-Q
• Company Name: LOTFANCY INC.
• Labeler DUNS: 009651371
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-25
• Public Version: 4
• Public Version Date: 2021-08-24
• Public Version Status: Update
• Public Device Record Key: d742cd11-7d4e-4d36-9e28-85800086d124

Device Description

Wrist Type Blood Pressure Monitor BP11

Device Characteristics

• Single Use: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• 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
18107	Noninvasive blood pressure physical simulator	An instrument designed to mimic the pressure variations acting on the cuff of noninvasive arterial blood pressure monitoring/measuring devices when placed on a patient's arm. It typically simulates blood pressure values (e.g., systolic, diastolic, mean) and abnormal states (e.g, hypertensive, hypotensive). It usually consists of an internal pump to generate the testing pressures, manometers, electronic circuitry, and a display. The device is used to test oscillometric noninvasive blood pressure monitors and electronic sphygmomanometers as a complete set including the transducer; some may also be used to test auscultatory sphygmomanometers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04710953420768	GS1