AeroFly Wheelchair, 18”, Gray, SF

GUDID 00822383030142

Drive Devilbiss Healthcare

Push-rim manual wheelchair, non-bariatric

• Primary Device ID: 00822383030142
• NIH Device Record Key: b9f5f669-90df-4e0a-aa6a-0bae7615a63a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroFly Wheelchair, 18”, Gray, SF
• Version Model Number: AF18FDAGY-SF
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383030142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232199

FDA Product Code

• IOR: Wheelchair, Mechanical

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: 2025-11-26
• Device Publish Date: 2025-11-18

Devices Manufactured by Drive Devilbiss Healthcare

• 00822383030135 - AeroFly Wheelchair, 18”, Black, SF: 2025-11-26
• 00822383030142 - AeroFly Wheelchair, 18”, Gray, SF: 2025-11-26
• 00822383030142 - AeroFly Wheelchair, 18”, Gray, SF: 2025-11-26
• 00822383033204 - AeroFly Wheelchair 20:, Black, SF: 2025-11-19
• 00822383033211 - AeroFly Wheelchair 20:, Gray, SF: 2025-11-19
• 00822383033228 - AeroFly Transport Chair, 18", Black: 2025-11-19
• 00822383033235 - AeroFly transport Chair, 18", Gray: 2025-11-19
• 00822383030333 - Drive: 2025-09-11
• 00822383000190 - Drive: 2025-09-10 35" BRNWOOD BEDEND W/SC05,OSLO FM,EA