LotFancy

GUDID 16970384257790

LOTFANCY INC.

Automatic-inflation electronic sphygmomanometer, portable, finger Automatic-inflation electronic sphygmomanometer, portable, finger Automatic-inflation electronic sphygmomanometer, portable, finger Automatic-inflation electronic sphygmomanometer, portable, finger

• Primary Device ID: 16970384257790
• NIH Device Record Key: 3922e1a4-6f07-4d20-9706-762044f68c0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LotFancy
• Version Model Number: 11C-1880-H
• Company DUNS: 009651371
• Company Name: LOTFANCY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970384257793 [Primary]
GS1	16970384257790 [Package]; Contains: 06970384257793; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130925

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-02-16

On-Brand Devices [LotFancy]

• 10697038425119: 11C-1899-A
• 16970384257790: 11C-1880-H
• 16970384256793: 11C-1879-G
• 06970384253207: 11C-1876-D
• 06970384252200: 11C-1875-C
• 06970384251203: 11C-1874-B
• 06970384250503: 11C-1827-G
• 06970384250206: 11C-1828-H
• 04710953420768: Wrist Type Blood Pressure Monitor BP11