Santamedical

GUDID 00858759005391

GURIN PRODUCTS LLC

Pulse oximeter, battery-powered

• Primary Device ID: 00858759005391
• NIH Device Record Key: 386666e5-54b3-480a-b877-d6954db894a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Santamedical
• Version Model Number: SM-165
• 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	00858759005391 [Primary]
GS1	10858759005398 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-08

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