REPAIR PART

GUDID 10848530104266

PE Valve for Invacare Platinum (IRC10LXO2, IRC5LXO2), Perfecto (IRC5PO2) and the PerfectoV (IRC5PO2V) #1143578

SUNSET HEALTHCARE SOLUTIONS, INC.

Mobile/portable oxygen concentrator

• Primary Device ID: 10848530104266
• NIH Device Record Key: 6169bedf-8fa7-4463-ba7e-e692e506bf45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REPAIR PART
• Version Model Number: RP003
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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	00848530104269 [Primary]
GS1	10848530104266 [Package]; Contains: 00848530104269; Package: [40 Units]; In Commercial Distribution

FDA Product Code

• BYX: Tubing, Pressure And Accessories

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: 2025-09-04
• Device Publish Date: 2025-08-27

On-Brand Devices [REPAIR PART]

• 10848530104266: PE Valve for Invacare Platinum (IRC10LXO2, IRC5LXO2), Perfecto (IRC5PO2) and the PerfectoV (IRC5
• 00848530107659: Lip Seal for Helios - Metal