SpO2 Sensor

GUDID 00848530105327

Sunset SPO2 Sensor - Neonatal/Adult (<3 kg or >40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable

SUNSET HEALTHCARE SOLUTIONS, INC.

Pulse oximeter probe, reusable

• Primary Device ID: 00848530105327
• NIH Device Record Key: 620a4c97-49af-4799-b80b-d86cb7938d55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpO2 Sensor
• Version Model Number: RES7200
• 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
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530105327 [Primary]

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: 2025-05-29
• Device Publish Date: 2025-05-21

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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• 00848530099640 - Tracheostomy and Suction Accessory: 2025-05-29 Suction Canister Disposable 1200CC - 48/Case
• 00848530105327 - SpO2 Sensor: 2025-05-29Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable
• 00848530105327 - SpO2 Sensor: 2025-05-29 Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable
• 00848530106119 - Pediatric Cannula: 2025-05-29 Pediatric Soft Cannula with 7ft. Supply Tube, Universal Connector
• 00848530106126 - Infant Cannula: 2025-05-29 Infant Soft Cannula with 7ft. Supply Tube, Universal Connector