3B Luna Style Ultrafine Filters CF8005

GUDID 00848530082048

3B Luna Style Ultrafine Filters (12/pack)

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, reusable

• Primary Device ID: 00848530082048
• NIH Device Record Key: f6e60632-b690-44b2-abef-7dc1a53f0867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Luna Style Ultrafine Filters
• Version Model Number: CF8005
• Catalog Number: CF8005
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 12
• 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	00848530082048 [Primary]
GS1	10848530082045 [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

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