Sunset Healthcare Mini in-line HME, for neonatal RES027NE

GUDID 20848530082011

Sunset Healthcare Mini in-line HME, for neonatal

SUNSET HEALTHCARE SOLUTIONS, INC.

Heat/moisture exchanger, single-use

• Primary Device ID: 20848530082011
• NIH Device Record Key: 4489eab4-fc43-4288-806e-435cac8b620a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Mini in-line HME, for neonatal
• Version Model Number: RES027NE
• Catalog Number: RES027NE
• 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: true
• 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	00848530082017 [Primary]
GS1	10848530082014 [Package]; Contains: 00848530082017; Package: [30 Units]; In Commercial Distribution
GS1	20848530082011 [Package]; Contains: 10848530082014; Package: [27 Units]; In Commercial Distribution

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

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: 2018-10-22
• Device Publish Date: 2018-09-21

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