SpO2 Sensor

GUDID 10848530105348

Sunset SPO2 Sensor - Infant (3-20kg) - 1.5ft cord

SUNSET HEALTHCARE SOLUTIONS, INC.

Pulse oximeter probe, reusable

• Primary Device ID: 10848530105348
• NIH Device Record Key: b008bd39-e2ae-4fd3-9089-d4fe9c375987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Sensor
• Version Model Number: RES7203
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530105341 [Primary]
GS1	10848530105348 [Package]; Contains: 00848530105341; Package: [20 Units]; In Commercial Distribution
GS1	20848530105345 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070371

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: 2025-06-11
• Device Publish Date: 2025-06-03

On-Brand Devices [SpO2 Sensor]

• 00848530105327: Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON
• 00848530105358: Sunset SPO2 Sensor - Pediatric (10-50kg) - 1.5ft cord
• 10848530105348: Sunset SPO2 Sensor - Infant (3-20kg) - 1.5ft cord
• 00848530105334: Sunset SPO2 Sensor - Neonatal/Adult 3ft cord- NON-replaceable