oximeter - RO2

GUDID 00382098017062

The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

Raya Pharmaceuticals LLC

Pulse oximeter probe, reusable

• Primary Device ID: 00382098017062
• NIH Device Record Key: 6797ef4f-8ec9-4b77-8802-2a2fc381db50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: oximeter - RO2
• Version Model Number: 1
• Company DUNS: 106631637
• Company Name: Raya Pharmaceuticals LLC
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382098017062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191430

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: 2024-11-08
• Device Publish Date: 2024-10-31

Devices Manufactured by Raya Pharmaceuticals LLC

• 00382098017062 - oximeter - RO2: 2024-11-08The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
• 00382098017062 - oximeter - RO2: 2024-11-08 The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the fing
• 06974289400223 - polymer patient examination glove - RayaNit: 2024-11-08 Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the exam
• 06974289400353 - polymer patient examination glove - RayaNit: 2024-11-08 Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the exam
• 06974289400360 - polymer patient examination glove - RayaNit: 2024-11-08 Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the exam
• 00382098010506 - Derma-R Cream: 2024-11-06 Derma-R Cream is a non-sterile formulation intended for topical application. It is intended for management of pruritus and Dryne