LotFancy

GUDID 10697038425119

LOTFANCY INC.

Aneroid manual sphygmomanometer

• Primary Device ID: 10697038425119
• NIH Device Record Key: c33277cd-27a5-4118-bfc7-13710f81532a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LotFancy
• Version Model Number: 11C-1899-A
• 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	00697038425112 [Primary]
GS1	10697038425119 [Package]; Contains: 00697038425112; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092245

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-19

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