Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)

GUDID 10848530103559

Pediatric Two Piece Trach Ties, 2x35.5cm (14in) - 20/box

SUNSET HEALTHCARE SOLUTIONS, INC.

Tracheostomy tube neck holder, single-use

• Primary Device ID: 10848530103559
• NIH Device Record Key: 073758e7-3390-4fde-9cf4-8166a277ab25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)
• Version Model Number: RES030P-14
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530103552 [Primary]
GS1	10848530103559 [Package]; Contains: 00848530103552; 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: 2024-03-28
• Device Publish Date: 2024-03-20

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

• 00848530108298 - CPAP Filter: 2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack
• 00848530107932 - Nebulizer and Compressor: 2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
• 10848530108127 - Regulator: 2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM
• 00848530108137 - CPAP Filter: 2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack
• 10848530108158 - Regulator: 2026-02-03 Standard CGA 870 Regulator, 1 DISS, 0-25LPM - BULK
• 00848530108304 - Repair Parts: 2026-02-03 Attendant/Direct Supply Cabinet with Door - 2/BX
• 10848530108226 - REPAIR PART: 2026-01-27 Drive Capacitor SSP 5 Liter (OEM# 525D-616)
• 00848530108236 - REPAIR PARTS: 2026-01-27 Drive Power Cord Strap (OEM# MC29D-657) - 10/PK