Bariatric Reclining Wheelchair 26" with Elevating Leg Rest

GUDID 00840117322684

DYNAREX CORPORATION

Push-rim manual wheelchair, bariatric

• Primary Device ID: 00840117322684
• NIH Device Record Key: fd5126ad-749d-4af5-88ec-6371df0789ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bariatric Reclining Wheelchair 26" with Elevating Leg Rest
• Version Model Number: 15015-26DELR
• 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117322684 [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: 2024-05-16
• Device Publish Date: 2024-05-08

Devices Manufactured by DYNAREX CORPORATION

• 00840117326620 - Resp-O2 Homecare 800 cc Suction Disposable Canister Full Kit: 2024-12-23 Includes: 800 cc Canister with Float Lid, 1/3" x 6' Suction Tubing, Ridged Elbow Connector, Soft Elbow Connector, Hydrophobic Sh
• 00840117339057 - Durma+ Transparent Film Dressing, Frame Style, Sterile: 2024-12-23 Sterile-EO, Size: 2.36" x 2.75" (6 cm x 7 cm)
• 00840117339088 - Durma+ Transparent Film Dressing, Frame Style, 4" x 4.75" (10 cm x 12 cm ): 2024-12-23 Sterile-EO
• 00840117340213 - Overbed Table H Base, Silver Vein, Walnut: 2024-12-23
• 00840117340220 - Overbed Table, H Base, Silver Vein, Mahogany: 2024-12-23
• 00840117340237 - Overbed Table, H Base, Silver Vein, Oak: 2024-12-23
• 00840117340343 - Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink: 2024-12-09
• 00840117340510 - Resp-O2 Disposable Guedel Airway, 50 mm, Infant, Blue: 2024-12-09