Touch

GUDID 10860005561725

Pulse oximeter.

LEXINGTON WELLNESS HOLDINGS INC.

Pulse oximeter, battery-powered

• Primary Device ID: 10860005561725
• NIH Device Record Key: e90281e2-e01f-4026-ab20-752156132bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Touch
• Version Model Number: JPD-500G
• Company DUNS: 079437338
• Company Name: LEXINGTON WELLNESS HOLDINGS 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	00860005561728 [Primary]
GS1	10860005561725 [Package]; Contains: 00860005561728; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140582

FDA Product Code

• DQA: Oximeter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-08
• Device Publish Date: 2021-08-31

Devices Manufactured by LEXINGTON WELLNESS HOLDINGS INC.

• 10860005561732 - Balance: 2023-08-24 Body composition scale. 200kg model.
• 00863398000225 - Beat: 2023-07-04 Upper arm blood pressure monitor.
• 10860005561725 - Touch: 2021-09-08Pulse oximeter.
• 10860005561725 - Touch: 2021-09-08 Pulse oximeter.
• 00860005561704 - Scan: 2021-02-09 Blood glucose meter test strips.
• 00863398000294 - Scan: 2021-02-09 Blood glucose meter.
• 10863398000277 - Balance: 2020-11-09 Body composition scale.
• 10863398000284 - Beat: 2020-10-09 Upper arm blood pressure monitor.
• 00834450009159 - IdealSmart: 2019-02-15 Body composition scale.