RD SET

GUDID 00843997013222

Neonatal/Adult Pulse Oximeter Adhesive Sensor

MASIMO CORPORATION

Pulse oximeter probe, single-use

• Primary Device ID: 00843997013222
• NIH Device Record Key: 5a338e12-c7d0-4b68-ac9f-6a057029e8e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RD SET
• Version Model Number: 4473
• Company DUNS: 780421038
• Company Name: MASIMO CORPORATION
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com
• Phone: +1(949)297-7498
• Email: TechService-US@masimo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843997013222 [Unit of Use]
GS1	10843997013229 [Primary]

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [RD SET]

• 10843997009666: Newborn Infant/Pediatric Pulse Oximeter Adhesive Sensor
• 10843997009659: Newborn Neonatal Pulse Oximeter Adhesive Sensor
• 10843997009642: Trauma Adult Pulse Oximeter Adhesive Sensor
• 00843997014298: RD SET DBI Adult Soft Reusable Sensor
• 00843997013086: TF-1 Adult Reusable Forehead Sensor
• 00843997013079: YI Multisite Pulse Oximeter Reusable Sensor
• 00843997009904: TC-1 Adult Reusable Ear Sensor
• 00843997013314: Neonatal Pulse Oximeter Adhesive Sensor
• 00843997013260: Neonatal/Adult Pulse Oximeter Adhesive Sensor
• 00843997013253: Infant Pulse Oximeter Adhesive Sensor
• 00843997013246: Pediatric Pulse Oximeter Adhesive Sensor
• 00843997013239: Adult Pulse Oximeter Adhesive Sensor
• 00843997013222: Neonatal/Adult Pulse Oximeter Adhesive Sensor
• 00843997013215: Infant Pulse Oximeter Adhesive Sensor
• 00843997013208: Pediatric Pulse Oximeter Adhesive Sensor
• 00843997013192: Adult Pulse Oximeter Adhesive Sensor
• 00843997011785: Blue Neonatal/Infant/Pediatric Pulse Oximeter Adhesive Sensor
• 00843997009669: RD SET Newborn Infant/Pediatric Pulse Oximeter Adhesive Sensor
• 00843997009591: RD SET Neo SpO2, PR, PI, PVI Neonatal/Adult Pulse Oximeter Adhesive Sensor
• 00843997009584: RD SET Inf SpO2, PR, PI, PVI Infant Pulse Oximeter Adhesive Sensor
• 00843997009577: RD SET Pdt SpO2, PR, PI, PVI Pediatric Pulse Oximeter Adhesive Sensor
• 00843997014571: RD SET CS Training Kit
• 00843997013307: RD SET NeoPt CS-2 Adhesive Sensor
• 00843997010993: RD SET Neo CS-1 Adhesive Sensor, 20/Box
• 00843997010986: RD SET Adt CS-1 Adhesive Sensor, 20/Box