DynaRide Series 5 Ultra Lite Wheelchair 18"

GUDID 00616784028019

DYNAREX CORPORATION

Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

• Primary Device ID: 00616784028019
• NIH Device Record Key: 422b12e4-4659-4c2e-9728-e8ccd4e3c3b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaRide Series 5 Ultra Lite Wheelchair 18"
• Version Model Number: 10280
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: false
• Manufacturing Date: false
• 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	00616784028019 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023993

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: 2022-11-22
• Device Publish Date: 2022-11-14

Devices Manufactured by DYNAREX CORPORATION

• 00840117341210 - Medicine Cups 1oz: 2024-11-05
• 00840117312906 - Resp-O2 Endotracheal Tube Cuffed, 4.0 mm: 2024-11-01 Sterile-EO
• 00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm: 2024-11-01 Sterile-EO
• 00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm: 2024-11-01 Sterile-EO
• 00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm: 2024-11-01 Sterile-Eo
• 00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm: 2024-11-01 Sterile-Eo
• 00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm: 2024-11-01 Sterile-Eo
• 00840117313026 - Resp-O2 Endotracheal Tube Cuffed, 7.0 mm: 2024-11-01 Sterile-Eo