Community Hospice of N.E. Florida

GUDID 50822383511905

Comm-Hospice, PowerNeb Ultra, 1/ea

Drive Devilbiss Healthcare

Nebulizing system, non-heated Nebulizing system, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated Benchtop nebulizer, non-heated

• Primary Device ID: 50822383511905
• NIH Device Record Key: ee515d02-0994-4a86-8e1f-3e15a76d002f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Community Hospice of N.E. Florida
• Version Model Number: 18080-COM
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383511900 [Primary]
GS1	50822383511905 [Package]; Contains: 00822383511900; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

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: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by Drive Devilbiss Healthcare

• 00822383004075 - Drive: 2024-04-18 Product Description CMS Fingertip Pulse Oximeter 1/ea
• 00822383024592 - M4 Valor Wheelchair 16": 2024-03-05 M4 Valor Bariatric Wheelchair 16”, Universal armrests, Swing-away Footrests
• 00822383024608 - M4 Valor Wheelchair 18": 2024-03-05 M4 Valor Wheelchair 18”, Universal armrests, Swing-away Footrests
• 00822383024615 - M4 Valor Wheelchair 20”,: 2024-03-05 M4 Valor Wheelchair 20”, Universal armrests, Swing-away Footrests
• 10822383138159 - Drive: 2024-01-31 Cane,Offset,BlueWave,6/cs
• 00311917203164 - Walgreens: 2024-01-30 Canes & Crutches Crutches Product Description Walgreens Univ. EZ Adj Crutch 1PR,8PR/CV
• 00885304032502 - DeVilbiss: 2024-01-30 Product Description iGO2 Portable oxygen Concentrator kit-NA
• 00822383023120 - DRIVEMEDICAL: 2023-05-16 RespiratoryNebs Product Description: 3050-2 w/ AdltMask (115014), 1/ea,8/cv