Heat Moisture Exchanger

GUDID 10848530103634

Sunset Trach HME with O2 Port (OEM# 1190)

SUNSET HEALTHCARE SOLUTIONS, INC.

Heat/moisture exchanger, single-use

• Primary Device ID: 10848530103634
• NIH Device Record Key: 3e98f4d1-6b15-4288-88f0-b12dd84a5d8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heat Moisture Exchanger
• Version Model Number: RES027UOP
• Company DUNS: 141668116
• Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.
• Device Count: 50
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com
• Phone: 8775786738
• Email: customerservice@sunsethcs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530103637 [Primary]
GS1	10848530103634 [Unit of Use]

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: 2024-08-08
• Device Publish Date: 2024-07-31

On-Brand Devices [Heat Moisture Exchanger]

• 00848530083298: Disposable, In-line HME
• 00848530083274: Heat Moisture Exchange Large Volume
• 10848530103634: Sunset Trach HME with O2 Port (OEM# 1190)
• 20848530096957: Sunset T HME with O2 Port
• 20848530096940: Sunset Healthcare Mini in-line HME, for neonatal
• 20848530096926: Sunset Flex HME
• 00848530096908: Sunset T HME
• 20848530062310: T Heat Moisture Exchanger