Drawstring Bag 13in x 12in BAGDS1312

GUDID 00848530089061

Drawstring Bag 13in x 12in

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00848530089061
• NIH Device Record Key: a539e9f3-049b-4aac-b3d1-cd099b231767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drawstring Bag 13in x 12in
• Version Model Number: BAGDS1312
• Catalog Number: BAGDS1312
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-578-6738
• Email: customerservice@sunsethcs.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530089061 [Primary]
GS1	10848530089068 [Package]; Package: [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063268

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-24

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