3B Luna Style Ultrafine Filter CF8005-2

GUDID 00848530084387

3B Luna Style Ultrafine Filter (2/pack)

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, reusable

• Primary Device ID: 00848530084387
• NIH Device Record Key: 0f3a25b9-a8bf-4894-890f-a967d923facd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Luna Style Ultrafine Filter
• Version Model Number: CF8005-2
• Catalog Number: CF8005-2
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 2
• 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: false
• 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: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530084387 [Primary]
GS1	10848530084384 [Unit of Use]

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: 2018-07-05
• Device Publish Date: 2018-06-04

On-Brand Devices [3B Luna Style Ultrafine Filter]

• 00848530084387: 3B Luna Style Ultrafine Filter (2/pack)
• 00848530082451: 3B Luna Style Ultrafine Filter (1/pack)