Oxygen Concentrator

GUDID 00616784080017

DYNAREX CORPORATION

Stationary oxygen concentrator

• Primary Device ID: 00616784080017
• NIH Device Record Key: 563178c1-154e-4677-a34f-f7efdadfdf49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxygen Concentrator
• Version Model Number: 10800
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784080017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131968

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2019-08-28
• Device Publish Date: 2019-08-20

Devices Manufactured by DYNAREX CORPORATION

• 00840117340336 - Resp-O2 Nebulizer Tee Connector, Standard 22 mm x OD x 18 mm ID x 22 mm OD: 2025-10-07 Connections
• 00840117340428 - Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender: 2025-10-07
• 00616784150529 - Adhesive Tape Remover Pads, For Professional and Hospital Use: 2025-10-06
• 00810180842303 - Dynarex Skincote Protective Dressing Applicators, 1.25" x 2.68": 2025-10-06 (3.25 cm x 6.81 cm)
• 00616784191027 - DynaFit Graduated Compression Anti-Embolism Stocking,Small: 2025-10-06 Knee Moderate (15-20 MMHG) Compression
• 00616784191119 - DynaFit Graduated Compression Anti-Embolism Stocking, Medium Knee: 2025-10-06
• 00616784191218 - DynaFit Graduated Compression Anti-Embolism Stocking, Large Knee: 2025-10-06
• 00616784191317 - DynaFit Graduated Compression Anti-Embolism Stocking, X-Large Knee: 2025-10-06