Oxygen, Bacteria & HEPA Filter

GUDID 00084853000905

Filter, Hydrophobic, Set, Barb 3/pack

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia conduction filter

• Primary Device ID: 00084853000905
• NIH Device Record Key: 9819c8fe-51ad-48d1-9a9b-cc27b513c546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxygen, Bacteria & HEPA Filter
• Version Model Number: AMED014BF1412-3
• 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	00084853000905 [Primary]

FDA Product Code

• JRL: Unit, Filter, Membrane

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: 2025-06-26
• Device Publish Date: 2025-06-18

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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• 00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large: 2025-07-30 CPAP Mask with cushion and headgear - Large
• 00848530106485 - Perform Health PrecisionFit Full Face Cushion - Small: 2025-07-30 CPAP Cushion - Small
• 00848530106492 - Perform Health PrecisionFit Full Face Cushion - Medium: 2025-07-30 CPAP Cushion - Medium
• 00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large: 2025-07-30 CPAP Cusion - Large
• 10848530106710 - CPAP Carry Bag for ResMed AirSense 11: 2025-07-29 CPAP Carry Bag
• 00848530106447 - Oxygen Kit: 2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)