Breeze Quiet One Kit OF11001SP

GUDID 00848530051198

This kit contains: 2 OF1005 Foam Cabinet Filters, 1 BF316 Final Bacteria Filter, 1 BFH6S 6in HEPA Capsule

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use

• Primary Device ID: 00848530051198
• NIH Device Record Key: 45385061-cf37-477b-b079-f95e53959a04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breeze Quiet One Kit
• Version Model Number: OF11001SP
• Catalog Number: OF11001SP
• 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: true
• 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	00848530051198 [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: 2018-08-31
• Device Publish Date: 2018-07-31

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