Sesoronics

GUDID 00851457007278

SENSORONICS INCORPORATED

Pulse oximeter, battery-powered

• Primary Device ID: 00851457007278
• NIH Device Record Key: c9b11318-492e-4e52-8c5d-a4c6086dd66a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sesoronics
• Version Model Number: SPO500
• Company DUNS: 079579147
• Company Name: SENSORONICS INCORPORATED
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851457007278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090671

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: 2019-10-07
• Device Publish Date: 2019-09-27

Devices Manufactured by SENSORONICS INCORPORATED

• 00851457007292 - Sensoronics: 2019-11-08
• 00851457007278 - Sesoronics: 2019-10-07
• 00851457007278 - Sesoronics: 2019-10-07
• 00851457007285 - Sensoronics: 2019-10-07
• 00851456007156 - Sensoronics: 2018-07-06
• 00851456007163 - Sensoronics: 2018-07-06
• 00851456007170 - Sensoronics: 2018-07-06
• 00851456007187 - Sensoronics: 2018-07-06
• 00851456007194 - Sensoronics: 2018-07-06