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

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