Carolina Breathing

GUDID 00822383295169

Carolina Breathing, Sportneb

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: 00822383295169
• NIH Device Record Key: de0bf001-e212-4f17-b259-e6f35284a62c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carolina Breathing
• Version Model Number: 3050-2-CABRPN
• 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	00822383295169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

FDA Product Code

• BTI: Compressor, air, portable

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: 2016-09-16

Devices Manufactured by Drive Devilbiss Healthcare

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• 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