Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Adult RES030

GUDID 10848530062238

Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Adult

SUNSET HEALTHCARE SOLUTIONS, INC.

Tracheostomy tube neck holder, single-use

• Primary Device ID: 10848530062238
• NIH Device Record Key: 580d9178-5b92-4c09-83a0-5cc837e262c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Adult
• Version Model Number: RES030
• Catalog Number: RES030
• 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: true
• 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	00848530062231 [Primary]
GS1	10848530062238 [Package]; Contains: 00848530062231; Package: [20 Units]; In Commercial Distribution

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

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

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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