Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask RES092

GUDID 00848530060800

Pediatric Nebulizer Kit - Disposable - w/ Jet Nebulizer, Pediatric Aerosol Mask, 7ft O2 tube - 50/cs

SUNSET HEALTHCARE SOLUTIONS, INC.

Nebulizing system delivery set, single-use

• Primary Device ID: 00848530060800
• NIH Device Record Key: 4878e4b0-59ac-473a-849c-448f66038482
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask
• Version Model Number: RES092
• Catalog Number: RES092
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848530060800 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-06-13
• Device Publish Date: 2016-09-24

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