6IN HEPA Capsule with Removable Sticker

GUDID 00848530104436

6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum 5 and 10 TM, and PerfectO2TM

SUNSET HEALTHCARE SOLUTIONS, INC.

Respirator filter/cartridge, particulates

• Primary Device ID: 00848530104436
• NIH Device Record Key: c79bb5bd-6517-4ece-a19a-36d2eda42ff3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 6IN HEPA Capsule with Removable Sticker
• Version Model Number: CS204
• 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: 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
• 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	00848530104436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102483

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2025-05-21
• Device Publish Date: 2025-05-13

On-Brand Devices [6IN HEPA Capsule with Removable Sticker ]

• 00848530010690: 6in HEPA Capsule with Removable Sticker (1/pack)
• 00848530104436: 6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum