Santamedical

GUDID 10858759005602

Santamedical Sports/Aviation Pulse Oximeter

GURIN PRODUCTS LLC

Pulse oximeter, battery-powered

• Primary Device ID: 10858759005602
• NIH Device Record Key: 289074ea-4565-4a34-825d-6ac6aa4e0849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Santamedical
• Version Model Number: SM-150Y
• Company DUNS: 022069446
• Company Name: GURIN PRODUCTS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• 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	00858759005605 [Primary]
GS1	10858759005602 [Package]; Contains: 00858759005605; Package: [200 Units]; In Commercial Distribution

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2018-07-30
• Device Publish Date: 2018-06-29

On-Brand Devices [Santamedical]

• 10858759005602: Santamedical Sports/Aviation Pulse Oximeter
• 10858759005596: Santamedical Sports/Aviation Pulse Oximeter
• 10858759005589: Santamedical Sports/Aviation Pulse Oximeter
• 00858759005513: Santamedical Sports/Aviation Pulse Oximeter
• 10858759005503: Santamedical Sports/Aviation Pulse Oximeter
• 10858759005497: Santamedical Sports/Aviation Pulse Oximeter
• 00858759005483: Santamedical Sports/Aviation Pulse Oximeter
• 00858759005391: SM-165