Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit NEB100

GUDID 00848530087326

Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit

SUNSET HEALTHCARE SOLUTIONS, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 00848530087326
• NIH Device Record Key: 9eee3ebf-00bb-483c-8bd5-6fbe2f27ef69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
• Version Model Number: NEB100
• Catalog Number: NEB100
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530087326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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.

• 00848530060749 - Oxygen Cylinder Cart: 2025-05-29 Oxygen Cylinder Cart, Powder Coated, Adjustable Handle - For single tanks sizes E/D - 4/case
• 00848530093839 - Cough Assist Kit: 2025-05-29 Trach Kit 1 kit contains: RES014 (1 each), BF2200 (1 each), TUB06 (1 each)
• 00848530096137 - Nebulizer Kit: 2025-05-29 Compressor Nebulizer Kit 1 kit contains T-Piece, 7ft Supply Tube, 6in Aerosol Tube, and Jet Nebulizer
• 00848530097363 - Limb Elbow: 2025-05-29 Single Limb Elbow
• 00848530099640 - Tracheostomy and Suction Accessory: 2025-05-29 Suction Canister Disposable 1200CC - 48/Case
• 00848530105327 - SpO2 Sensor: 2025-05-29 Sunset SPO2 Sensor - Neonatal/Adult (40 kg) 1.5ft cord (Similar to Masimo 2329) NON-replaceable
• 00848530106119 - Pediatric Cannula: 2025-05-29 Pediatric Soft Cannula with 7ft. Supply Tube, Universal Connector
• 00848530106126 - Infant Cannula: 2025-05-29 Infant Soft Cannula with 7ft. Supply Tube, Universal Connector